Description Principal Biostatistician Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities o Collaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notably o design of experiments feasible under given lab conditions, o support of sample-size calculations and application for animal testing licenses, o randomization, o data transfer into appropriate stats software, o interpretation of results. o Takes statistical responsibility for one or more standard experiments. o Develops the statistical analysis plan for the experiments as appropriate, ensuring overall consistency within and between projects. o Facilitates the overall organization and coordination of statistical activities for specific experiments and small projects. o Leads virtual cross-functional sub-teams within NCS/SIS of DS&AI. o Assumes responsibility for the production and accuracy of the statistical deliverables and interpretation of the results. o Works independently at routine and complex statistical questions and tasks. o Develops and implements standard processes for the analysis of routine experiments. o Oversees and ensures accurate and timely delivery of statistical work outsourced to external providers. Qualifications What we're looking for Qualifications & Competencies: o PhD or MSc in Biostatistics, Statistics or Mathematics, or related field. o Strong communication skills. o Ability to work independently as well as collaboratively, as required. o Ability to translate statistical results into biological meaning o Good knowledge of statistical programming languages (including SAS and R). o Fluent English skills. o At least two years as a non-clinical statistician focused on in vivo and in vitro experiments with significant time spent in pharma, biotech or similar sector.
Description Principal Statistical Programmer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities . Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. . Works to ensure that outputs meet quality standards and project requirements. . Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. . Keeps project team members informed of programming progress and issues requiring their attention. . Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). . Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. . Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. . Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. . Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. . Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. . Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. . Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. . Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. . Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. . Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. . Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements serves as a technical expert resource to other department members for complex programming questions. . Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. . Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. . When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards . When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) . When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. . Transfers deliverables. . Performs other work-related duties as assigned. . Minimal travel may be required Qualifications What we're looking for Must have more than 8 years experience in Clinical SAS programming Must have good experience in SDTM, ADAM programming, specification creation, TLFs Should have study lead experience of managing minimum 3 studies at a time. eSub Experience Define.xml Creation and Validation Creation/Validation of SDRG/ADRG Creation of eSub Packages to FDA Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade . Experience in mentoring others in clinical trial process and CDISC Standards. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about . Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Description Sr Biostatistician Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Description Safety PV Specialist II/ Principal PV Spl (11 months of Contract role, Mumbai) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities 8 Months Contract Role Candidates from Mumbai preferrable Min 4 yrs of relevant experience required Immediate joiners preferred Assist the CSH to collect and report ADRs/AEs and other safety relevant information. . Periodic Safety Report (PSR) Management: o Local periodic reports are handled in compliance with PSPV Quality Documents (QDs/SOPs) and local regulatory PV requirements. To assist in preparing local PSRs if and when required. Contribute together with PSPV and Regulatory Affairs (RA) department to the planning for periodic safety reports. Planning, tracking and monitoring of Master Planning Table and Affiliate Tracking Table (ATT) activity. Patient Program (PP) and Managed Access Program (MAP) Management: o support PP/MAP approval with validation of documents, ensure PP/MAP vendor PV training done before PP/MAP initiation and regular refresher trainings, as and when required. Monthly review of PP/ MAP vendor QC and reconciliation activity Perform regular audit of the QC check activity performed by vendor In case of local product in-licensing or local company acquisition: Participate, in close collaboration with GPE, in the due diligence and integration process as per available Company standards. In case of local agreements with pharmaceutical companies (license-in, license-out, co-marketing-co-promotion, divestment.), a local SDEA is in place and implemented, aligned with the local regulations and Global SDEA standards and regularly revised. That global SDEAs are implemented locally when applicable. Monthly validation of agreement with PV clause/SDEA with relevant stakeholders Complete global Business plan requirements (BPPQRA activity) Maintain MyAlliance database with latest and updated documents and information. Ensure appropriate PV requirement in contracts for all types of service agreements, Purchase Orders (PO's) (where applicable), etc. Maintain schedule and conduct PV awareness, PV refresher and PV induction training, as and when required. All safety-related questions raised by local Health Authorities are collated and immediately transmitted by e-mail to the GSO of the concerned GPE Business Unit and to the relevant GPE mailbox for evaluation and organization for further immediate communication within GPE and action as relevant. Product safety alerts are handled in accordance with company product alert processes. Local PV Alerts are managed and coordinated in collaboration with GPE, the relevant medical director and local Management. Assist in management of Product Recall Develop and maintain the local Pharmacovigilance System File (LPSF) in accordance with the global standards and local legislation. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Performs safety and pharmacovigilance program delivery activities including (but not limited to) all aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which includes cleaning and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ISCR reports, management of duplicate ICSR cases, Quality review of ICSRs, Substances, Products, Organizations and Referential (SPOR) / Identification of Medicinal Products (IDMP) activities)) and the preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.
Description Principal Statistical Programmers Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Develop and maintain statistical programming standards and best practices Provide technical expertise and leadership in the development of statistical programs Collaborate with statisticians and other stakeholders to understand and address their programming needs Ensure the accuracy and integrity of data and statistical outputs Troubleshoot and resolve programming issues and challenges Mentor and train junior programmers and other team members Contribute to the continuous improvement of programming processes and tools Design and implement efficient programming solutions to meet project requirements Conduct code reviews and provide constructive feedback to ensure high-quality programming deliverables Stay updated with the latest advancements in statistical programming and incorporate relevant techniques into practice Qualifications Advanced degree in Statistics, Computer Science, or a related field Extensive experience in statistical programming, preferably in a clinical or pharmaceutical setting Proficiency in programming languages such as SAS, R, or Python Strong understanding of statistical methods and data analysis techniques Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills Certifications SAS Certified Advanced Programmer for SAS 9 or equivalent certification preferred Necessary Skills Expertise in statistical programming and data analysis Proficiency in programming languages such as SAS, R, or Python Strong understanding of statistical methods and data analysis techniques Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Statistical Programming job family at the P23 level involve developing programs and providing statistical programming support for statisticians or for client or business use. This includes sourcing, organizing, and interpreting complex data sets by creating statistical tables, listings, and graphs. The role also involves developing codes to create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions to increase productivity. As a leading expert individual contributor, the P23 level professional is viewed as a valuable resource by peers and works to achieve organizational, functional, and business targets with measurable impact on department results. Impact and Contribution Roles within the Statistical Programming job family at the P23 level manage or contribute to projects, programs, or processes that span multiple related areas. They have comprehensive knowledge and skills in their professional discipline and understand the impact of their work on related areas. Their contributions are crucial in designing, implementing, and delivering processes, programs, and policies. They may direct the work of lower-level professionals or manage processes and programs, spending the majority of their time contributing to the design, implementation, or delivery of processes, programs, and policies using knowledge and skills typically acquired through advanced education. Core Focus . Developing programs and providing statistical programming support for statisticians or for client or business use . Sourcing, organizing, and interpreting complex data sets by creating statistical tables, listings, and graphs . Developing codes to create analysis datasets, tables, and figures . Evaluating programming processes and suggesting revisions to increase productivity . Managing or contributing to projects, programs, or processes that span multiple related areas . Directing the work of lower-level professionals or managing processes and programs . Contributing to the design, implementation, or delivery of processes, programs, and policies using advanced knowledge and skills
Description Senior Project Specialist (Hyderabad location) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Minimum3+ yearsof relevantproject specialist experience. Excellent proficiency inAdvanced Microsoft Excel, including Pivot tables,VLOOKUP/XLOOKUP and Complex formulas Leadmonthly finance activitiesand providefinancial analysisto support decision-making. Maintain and enhancefinancial tracking toolsand documentation. Collaborate withinternal teamsandexternal stakeholdersto ensure accurate and timely reporting. Candidate from Hyderabad and Gurgaon preferre d Set-up, maintain and close out project files and study information ((e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. Maintain and distribute study-specific /financial reports (e.g. vendor/site invoices, investigator payments (grants and pass-through), forecasts, etc). May lead internal and external meetings as directed by the PL Prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure. Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL. Assesses and communicates KPIs for associated job tasks to PL with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PL Ensure all study documents are archived based on the appropriate guidelines and policy. May serve as project representative for internal and external audits. Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution actionable issues. May serve as primary customer contact when PL is out of the office. Seeks input from Project Director for customer support. May mentor and train Project Specialists Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary The Senior Project Specialist is responsible for maintaining and coordinating the logistical aspects of clinical projects, and provides overall support to functional leads to ensure the successful completion of project deliverables The Senior Project Specialists supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers requirements. Operate independently, with minimal day to day oversight, and may co-ordinate the activities of Project Specialists
Description Sr Biostatistician Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Description Principal Statistical Programmers Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Develop and maintain statistical programming standards and best practices Provide technical expertise and leadership in the development of statistical programs Collaborate with statisticians and other stakeholders to understand and address their programming needs Ensure the accuracy and integrity of data and statistical outputs Troubleshoot and resolve programming issues and challenges Mentor and train junior programmers and other team members Contribute to the continuous improvement of programming processes and tools Design and implement efficient programming solutions to meet project requirements Conduct code reviews and provide constructive feedback to ensure high-quality programming deliverables Stay updated with the latest advancements in statistical programming and incorporate relevant techniques into practice Qualifications Advanced degree in Statistics, Computer Science, or a related field Extensive experience in statistical programming, preferably in a clinical or pharmaceutical setting Proficiency in programming languages such as SAS, R, or Python Strong understanding of statistical methods and data analysis techniques Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills Certifications SAS Certified Advanced Programmer for SAS 9 or equivalent certification preferred Necessary Skills Expertise in statistical programming and data analysis Proficiency in programming languages such as SAS, R, or Python Strong understanding of statistical methods and data analysis techniques Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Statistical Programming job family at the P23 level involve developing programs and providing statistical programming support for statisticians or for client or business use. This includes sourcing, organizing, and interpreting complex data sets by creating statistical tables, listings, and graphs. The role also involves developing codes to create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions to increase productivity. As a leading expert individual contributor, the P23 level professional is viewed as a valuable resource by peers and works to achieve organizational, functional, and business targets with measurable impact on department results. Impact and Contribution Roles within the Statistical Programming job family at the P23 level manage or contribute to projects, programs, or processes that span multiple related areas. They have comprehensive knowledge and skills in their professional discipline and understand the impact of their work on related areas. Their contributions are crucial in designing, implementing, and delivering processes, programs, and policies. They may direct the work of lower-level professionals or manage processes and programs, spending the majority of their time contributing to the design, implementation, or delivery of processes, programs, and policies using knowledge and skills typically acquired through advanced education. Core Focus . Developing programs and providing statistical programming support for statisticians or for client or business use . Sourcing, organizing, and interpreting complex data sets by creating statistical tables, listings, and graphs . Developing codes to create analysis datasets, tables, and figures . Evaluating programming processes and suggesting revisions to increase productivity . Managing or contributing to projects, programs, or processes that span multiple related areas . Directing the work of lower-level professionals or managing processes and programs . Contributing to the design, implementation, or delivery of processes, programs, and policies using advanced knowledge and skills
Description Principal Stat Programmer(Immediate Joiner) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Develop and maintain statistical programming standards and best practices Provide technical expertise and leadership in the development of statistical programs Collaborate with statisticians and other stakeholders to understand and address their programming needs Ensure the accuracy and integrity of data and statistical outputs Troubleshoot and resolve programming issues and challenges Mentor and train junior programmers and other team members Contribute to the continuous improvement of programming processes and tools Design and implement efficient programming solutions to meet project requirements Conduct code reviews and provide constructive feedback to ensure high-quality programming deliverables Stay updated with the latest advancements in statistical programming and incorporate relevant techniques into practice Qualifications Advanced degree in Statistics, Computer Science, or a related field Extensive experience in statistical programming, preferably in a clinical or pharmaceutical setting Proficiency in programming languages such as SAS, R, or Python Strong understanding of statistical methods and data analysis techniques Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills Certifications SAS Certified Advanced Programmer for SAS 9 or equivalent certification preferred Necessary Skills Expertise in statistical programming and data analysis Proficiency in programming languages such as SAS, R, or Python Strong understanding of statistical methods and data analysis techniques Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Statistical Programming job family at the P23 level involve developing programs and providing statistical programming support for statisticians or for client or business use. This includes sourcing, organizing, and interpreting complex data sets by creating statistical tables, listings, and graphs. The role also involves developing codes to create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions to increase productivity. As a leading expert individual contributor, the P23 level professional is viewed as a valuable resource by peers and works to achieve organizational, functional, and business targets with measurable impact on department results. Impact and Contribution Roles within the Statistical Programming job family at the P23 level manage or contribute to projects, programs, or processes that span multiple related areas. They have comprehensive knowledge and skills in their professional discipline and understand the impact of their work on related areas. Their contributions are crucial in designing, implementing, and delivering processes, programs, and policies. They may direct the work of lower-level professionals or manage processes and programs, spending the majority of their time contributing to the design, implementation, or delivery of processes, programs, and policies using knowledge and skills typically acquired through advanced education. Core Focus . Developing programs and providing statistical programming support for statisticians or for client or business use . Sourcing, organizing, and interpreting complex data sets by creating statistical tables, listings, and graphs . Developing codes to create analysis datasets, tables, and figures . Evaluating programming processes and suggesting revisions to increase productivity . Managing or contributing to projects, programs, or processes that span multiple related areas . Directing the work of lower-level professionals or managing processes and programs . Contributing to the design, implementation, or delivery of processes, programs, and policies using advanced knowledge and skills
Description Sr CDA (Data Acquisition Specialist-Non-CRF) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Job Summary This position is responsible for leading other Clinical Data Associates (CDA) in collection of Non-CRF data/data management activities, during study set-up, conduct and closeout activities for multiple studies, providing support and may function as a backup for the Project Data Manager (PDM) on a study as required for global clinical trials. Core Responsibilities Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary. Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required. Creates and enters test data for User Acceptance Testing (UAT) Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices. Receives and enters lab normal ranges. Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets. Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate. For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies. For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects. For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems. Participates/Leads in internal meetings. Attends in-process review meetings. Participates in internal/external audits as required. Files documentation in the Data Management Study File (DMSF). Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College) Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs. Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed. Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party. Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries. Runs data cleaning and/or status reports. Performs Serious Adverse Event (SAE) reconciliations. Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations. Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements). Perform post-migration testing on screens, edit checks, matrices and role changes as required. Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution. Reviews database design specifications (including configuration, data structures, annotated CRFs). Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design. Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance. Provides support to the PDM on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibility for an aspect of the study delivery, or producing study metrics reports. PDM's back up for specific activities (including attend sponsor's meetings to provide updates). Creation of Discoverer, BOXI, J-Review Reports Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines. Fills-in the Data Transfer Request Form required for delivering the data to sponsor or vendor. Reviews queries and self-evident corrections proposed by less experienced DM staff. Understands the coding process Understands the purpose of interim, dry run, data cut Trains and mentors DM staff providing timely feedback to trainee and management as appropriate. Trains project team in project specific requirements. Provides EDC training to internal and external team members via Teleconference. Serves as a platform or process-specific Subject Matter Expert (SME). Performs QC of DMSF after QuickStart Camp (QSC) and ongoing during the study conduct. May be required to participate in client, internal or agency audits and inspections May represent the department at business development related meetings. Implement, maintain, and approve non CRF Vendor Transfer Agreements/plans/ specifications and confirm non CRF vendor specifications can be met and provide expertise on testing/results. Effectively communicates non-CRF data collection deliverables, status of work and data issues to the Client study lead and other study team members. Coordinates cross-functional non-CRF tasks with good understanding of downstream processes and stakeholder needs and impacts. Receive, process, and deliver non CRF test and production data. Implementation of patient enrollment and randomization strategy responsible for set up of IXRS UAT. Provide comprehensive assessment to identify all non CRF data types defined in the study protocol via protocol review and team discussion (including amendments) Communicate independently, proactively, and clearly to internal and external stakeholders. Able to lead all the Non CRF activities of study independently Able to act as Non CRF POC for Customer leading Cross functional communication and Vendor collaboration Additional Qualifications. BA/BS degree in the biological sciences or related disciplines in the natural science/health care field. Must have 5 to 7years of experience in Clinical Data Management. Must have experience into external vendor data setup and non-CRF setup activities Must have experience in central lab. Experience into eCOA, ePRO, patient diaries, Device testing, sensor testing , Data transfer agreement, external data setup, Lab, ECG, IWRS/IVRS testing Data management startup, study setup. Experience with DM practices and relational database management software systems preferred. Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred. Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills. Work experience in clinical research, drug development, data management, or other healthcare environment preferred. Familiarity with medical terminology Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team. Ability to perform a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers. Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Non CRF Set-up , Leads the collection of non-CRF data, during study set-up, conduct and close out activities for multiple studies
Description The Scientific Team Lead, India , operates as a core member of the global Syneos Health medical communications business. This leader will have line management and content delivery responsibilities for a team of 3-5 local medical writers of varying levels of seniority and experience. They will require the ability to effectively partner with local leadership and other key stakeholders in the organisation's global medical communications ecosystem. For the group's medical communication agency, Cadent, the Scientific Team Lead, India is a discipline subject-matter expert, who will join the existing medical writing footprint in India to manage a highly effective medical writing team, delivering high-quality work for one of our portfolios of business. As such, this role is directly accountable to the Director of Scientific Services & Communications Group, India to ensure flawless and strategic execution in support of our global medical communications agencies, and to the satisfaction of our clients. We are currently looking for a Scientific Team Lead, India to lead the writing team within one of our medical communications portfolios / business units. The successful candidate will be a dynamic individual who has the necessary people management and technical skills to lead a team of writers from both an editorial and a strategic perspective. The Scientific Team Lead, India must demonstrate sound scientific knowledge and understanding, keen commercial acumen, an ability to think creatively and a talent for getting the best out of people, as well as a very high standard of writing ability. Technical skills: Managing the delivery of a range of high-quality medical communication materials across global programmes, including peer-to-peer programs, advisory boards, scientific platforms, MSL materials (proactive and reactive), digital medical communications and publications Experience across both non-promotional and promotional medical communication activities Ensuring maintenance of high scientific and editorial standards through first-pass review of other writers work, as part of defined quality control process Proven strategic and scientific thinking and the ability to read and distill data Providing strategic direction to team members, to support their delivery against content briefs, based on commercial needs of the business and thorough understanding of clients needs and objectives Developing specialist knowledge in specific therapy areas as required Ability to multi-task and collaborate internally and externally, to ensure delivery according to agreed project timelines Proven leadership and management of multiple accounts Talent Management: Leading and managing a team of 3-5 medical writers of all levels of seniority Capacity management, including allocation of medical writing tasks to ensure optimal utilization of resources and assignment of appropriate expertise to ensure efficient project delivery For the India medical writing team, support delivery of training, mentorship, and professional development opportunities to support high-quality medical writing and medical strategy execution Identifying, fostering, and monitoring necessary skills development for direct reports Supporting and maintaining a healthy local Communications employee culture that drives engagement and retention, and driving connectivity between the India-based Communications teams and the broader global Communications organization Providing detailed feedback on direct reports as part of annual performance reviews Partnering as needed with other Communications hiring managers and leaders in support of efficient recruitment and onboarding, working proactively to optimize and streamline processes and procedures Providing pastoral care and practical guidance to assist team members in the completion of their duties. Team Orientation/Collaboration: Allocating resources to ensure that projects are completed on time and within budget Ability to effectively multi-task and collaborate internally and externally Coordinating with studio, production and account management teams for project delivery Ability to grow and develop client relationships Identifying opportunities for new business within existing accounts Assisting in development and maintenance of new business pipeline Proactively contribute to the culture of the wider team Proactively contribute to Company meetings Acting as a role model and setting a visible example for professionalism and work ethic Acting as ambassador for the company internally and externally Advanced degree in biomedical field, PhD preferred Able to communicate fluently in the English language (written and verbal) Prior direct line management experience Minimum of 7 years professional medical writing and strategy experience in publication planning, publication delivery, medical affairs, medical education promotional, high-science communication experience is a plus Broad therapeutic category experience experience in oncology, aesthetics, immunology, and neuroscience preferred Strong understanding of pharmaceutical drug development, commercialisation and lifecycle management Comfortable operating within a highly-matrixed organization Strong client and industry relationships Excellent computer skills, including PowerPoint, Word, Excel Cadent is part of Syneos Health Communications, a purpose-built collective of agencies focused on supporting health and biopharmaceutical innovators. We work in scalable, collaborative teams that partner across disciplines and geographies to deliver integrated communications strategies that accelerate brand performance. In today's fast-changing and complex environment, success lies in making connections: between science, emotion and technology between data, design and human insight. We are able to make those connections because our advertising, public relations, medical communications, digital, data science, research and market access specialists work closely with each other and with healthcare experts, including physicians, pharmacists and advocates. Together, we are the connected healthcare partner tapping rich insights to drive innovation, change behavior and pioneer a new era of accountable marketing. Syneos Health Communications is powered by Syneos Health, a global professional services organization designed to help the biopharmaceutical industry shorten the distance from lab to life. WORK HERE MATTERS EVERYWHERE | How will you accelerate bringing new therapies to patients
Description Medical Scientist (MBBS / MD Qualified Only) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities ROLE RESPONSIBILITIES The Medical Monitor Contractor will serve as a critical member of the clinical team, responsible for ensuring the integrity and quality of clinical data and supporting clinical oversight activities. Key responsibilities include: Serving as a clinical team member assigned to data review for clinicians, including: Verification of subject eligibility based on medical history. Critical application of protocol-defined study requirements to assess data relevant to study endpoints (e.g., safety, tolerability, immunogenicity, efficacy). Reviewing serious and non-serious adverse events (AEs), including: Drafting and responding to site queries. Ensuring accurate and timely reconciliation of safety data. Reviewing reactogenicity data in eDiaries or EDC systems to ensure compliance with protocol-specified safety surveillance and monitoring. Assisting the lead clinician with: Aggregate data review and interpretation. Preparation and management of safety narratives. Slide development for internal and external presentations. Oversight or Participant in safety narrative authoring workflows. Supporting additional study-related tasks as required, such as: Literature reviews. Data cleaning. Review of training materials. Participating in safety surveillance meetings and contributing to PowerPoint creation as needed. Being available during normal business hours for the assigned region and working the specified number of hours per week. Additional responsibilities may be added based on prior experience, including study startup or conduct activities such as eDiary design, feasibility, informed consent document reviews, draft protocol reviews, safety presentations, and site interactions for safety follow up or protocol compliance and/or training. QUALIFICATIONS & SKILLS Medical degree (MD, DO, MBBS, or equivalent) required. Preferred: At least 2 years of direct patient care experience post-residency. Comfortable with complex medical reviews involving pediatric, adult, and obstetrical populations Required: Prior experience as a medical monitor, including: Safety data review (non-serious and serious AEs). Experience on an interventional clinical trial within the past 3 years (Vaccine trials preferred but not required). Familiarity with EDC platforms (InForm or RedCap preferred). Experience with J Review or a similar data review system is preferred. Strong ability to critically evaluate medical/scientific information. Understanding of clinical study design, development, and execution. Proficiency in Microsoft Word, PowerPoint, and Excel. Fluency in English (written and spoken). Ability to adapt to a fast-paced and evolving environment. Training and experience in infectious diseases and/or infection control in a hospital setting is preferred. Other relevant specialty experiences include: Family Medicine, Internal Medicine, Obstetrics and Gynecology, or Pediatrics Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Reviews safety and efficacy data and supports other task from lead medical monitor
Description Sr CDA (Data Acquisition Specialist-Non-CRF) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Job Summary This position is responsible for leading other Clinical Data Associates (CDA) in collection of Non-CRF data/data management activities, during study set-up, conduct and closeout activities for multiple studies, providing support and may function as a backup for the Project Data Manager (PDM) on a study as required for global clinical trials. Core Responsibilities Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary. Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required. Creates and enters test data for User Acceptance Testing (UAT) Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices. Receives and enters lab normal ranges. Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets. Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate. For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies. For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects. For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems. Participates/Leads in internal meetings. Attends in-process review meetings. Participates in internal/external audits as required. Files documentation in the Data Management Study File (DMSF). Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College) Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs. Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed. Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party. Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries. Runs data cleaning and/or status reports. Performs Serious Adverse Event (SAE) reconciliations. Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations. Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements). Perform post-migration testing on screens, edit checks, matrices and role changes as required. Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution. Reviews database design specifications (including configuration, data structures, annotated CRFs). Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design. Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance. Provides support to the PDM on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibility for an aspect of the study delivery, or producing study metrics reports. PDM's back up for specific activities (including attend sponsor's meetings to provide updates). Creation of Discoverer, BOXI, J-Review Reports Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines. Fills-in the Data Transfer Request Form required for delivering the data to sponsor or vendor. Reviews queries and self-evident corrections proposed by less experienced DM staff. Understands the coding process Understands the purpose of interim, dry run, data cut Trains and mentors DM staff providing timely feedback to trainee and management as appropriate. Trains project team in project specific requirements. Provides EDC training to internal and external team members via Teleconference. Serves as a platform or process-specific Subject Matter Expert (SME). Performs QC of DMSF after QuickStart Camp (QSC) and ongoing during the study conduct. May be required to participate in client, internal or agency audits and inspections May represent the department at business development related meetings. Implement, maintain, and approve non CRF Vendor Transfer Agreements/plans/ specifications and confirm non CRF vendor specifications can be met and provide expertise on testing/results. Effectively communicates non-CRF data collection deliverables, status of work and data issues to the Client study lead and other study team members. Coordinates cross-functional non-CRF tasks with good understanding of downstream processes and stakeholder needs and impacts. Receive, process, and deliver non CRF test and production data. Implementation of patient enrollment and randomization strategy responsible for set up of IXRS UAT. Provide comprehensive assessment to identify all non CRF data types defined in the study protocol via protocol review and team discussion (including amendments) Communicate independently, proactively, and clearly to internal and external stakeholders. Able to lead all the Non CRF activities of study independently Able to act as Non CRF POC for Customer leading Cross functional communication and Vendor collaboration Additional Qualifications. BA/BS degree in the biological sciences or related disciplines in the natural science/health care field. Must have 5 to 7years of experience in Clinical Data Management. Must have experience into external vendor data setup and non-CRF setup activities Must have experience in central lab. Experience into eCOA, ePRO, patient diaries, Device testing, sensor testing , Data transfer agreement, external data setup, Lab, ECG, IWRS/IVRS testing Data management startup, study setup. Experience with DM practices and relational database management software systems preferred. Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred. Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills. Work experience in clinical research, drug development, data management, or other healthcare environment preferred. Familiarity with medical terminology Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team. Ability to perform a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers. Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Non CRF Set-up , Leads the collection of non-CRF data, during study set-up, conduct and close out activities for multiple studies
Description Sr CDA (Data Acquisition Specialist-Non-CRF) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Job Summary This position is responsible for leading other Clinical Data Associates (CDA) in collection of Non-CRF data/data management activities, during study set-up, conduct and closeout activities for multiple studies, providing support and may function as a backup for the Project Data Manager (PDM) on a study as required for global clinical trials. Core Responsibilities Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary. Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required. Creates and enters test data for User Acceptance Testing (UAT) Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices. Receives and enters lab normal ranges. Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets. Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate. For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies. For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects. For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems. Participates/Leads in internal meetings. Attends in-process review meetings. Participates in internal/external audits as required. Files documentation in the Data Management Study File (DMSF). Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College) Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs. Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed. Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party. Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries. Runs data cleaning and/or status reports. Performs Serious Adverse Event (SAE) reconciliations. Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations. Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements). Perform post-migration testing on screens, edit checks, matrices and role changes as required. Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution. Reviews database design specifications (including configuration, data structures, annotated CRFs). Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design. Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance. Provides support to the PDM on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibility for an aspect of the study delivery, or producing study metrics reports. PDM's back up for specific activities (including attend sponsor's meetings to provide updates). Creation of Discoverer, BOXI, J-Review Reports Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines. Fills-in the Data Transfer Request Form required for delivering the data to sponsor or vendor. Reviews queries and self-evident corrections proposed by less experienced DM staff. Understands the coding process Understands the purpose of interim, dry run, data cut Trains and mentors DM staff providing timely feedback to trainee and management as appropriate. Trains project team in project specific requirements. Provides EDC training to internal and external team members via Teleconference. Serves as a platform or process-specific Subject Matter Expert (SME). Performs QC of DMSF after QuickStart Camp (QSC) and ongoing during the study conduct. May be required to participate in client, internal or agency audits and inspections May represent the department at business development related meetings. Implement, maintain, and approve non CRF Vendor Transfer Agreements/plans/ specifications and confirm non CRF vendor specifications can be met and provide expertise on testing/results. Effectively communicates non-CRF data collection deliverables, status of work and data issues to the Client study lead and other study team members. Coordinates cross-functional non-CRF tasks with good understanding of downstream processes and stakeholder needs and impacts. Receive, process, and deliver non CRF test and production data. Implementation of patient enrollment and randomization strategy responsible for set up of IXRS UAT. Provide comprehensive assessment to identify all non CRF data types defined in the study protocol via protocol review and team discussion (including amendments) Communicate independently, proactively, and clearly to internal and external stakeholders. Able to lead all the Non CRF activities of study independently Able to act as Non CRF POC for Customer leading Cross functional communication and Vendor collaboration Additional Qualifications. BA/BS degree in the biological sciences or related disciplines in the natural science/health care field. Must have 5 to 7years of experience in Clinical Data Management. Must have experience into external vendor data setup and non-CRF setup activities Must have experience in central lab. Experience into eCOA, ePRO, patient diaries, Device testing, sensor testing , Data transfer agreement, external data setup, Lab, ECG, IWRS/IVRS testing Data management startup, study setup. Experience with DM practices and relational database management software systems preferred. Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred. Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills. Work experience in clinical research, drug development, data management, or other healthcare environment preferred. Familiarity with medical terminology Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team. Ability to perform a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers. Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Non CRF Set-up , Leads the collection of non-CRF data, during study set-up, conduct and close out activities for multiple studies
Description Sr Clinical Programmer (EDC Programming-Rave/Veeva) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Job Summary Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. First level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations. Core Responsibilities . Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. . Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. . Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. . Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports . Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. . Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with inprogress audits. . Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders manages and executes the change order to completion. Provides input and supporting details for change orders. . Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. . Performs system integration activities, application updates, and user acceptance testing. . Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications uses expanded technical skills to meet evolving project needs. . Assists in project meetings and actively contributes and participates in departmental review meetings. . Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. . Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. . Manages project resources, proactively alerting management of delivery and resourcing needs. . Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Qualifications . Bachelor's degree preferred, or equivalent combination of related education and experience. . 5+ years of total experience, ability to Lead the Clinical Study Design and Specification documentation to support efficient Database Build activities. . Strong experience in Custom Function Programming (Min. 4 years of experience on Custom Function Programming). . Minimum 3 years of Experience on Migration (Post DB Changes) activities, preferably able to perform Impact Analysis. . Medidata Rave and iMedidata experience (Edit and form designing), Edit Check Programming and review, Understanding and Programming Dynamic edits, Experience in Global Libraries, Generating eCRF PDF Reports. . The ability to deal effectively with sponsors and internal customers at all levels. . Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. . Demonstrated experience in managing multiple priorities in a highly dynamic environment . Experience working in a matrix-structured environment is preferred . Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail . Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. . Ability to travel as necessary (up to 25%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. First level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations.
Description CRA II/ Sr CRA I (Mumbai Location, Client based) (Oncology) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Should have minimum 3- 5yrs of monitoring exp Should have experience of therapeutic area like Oncology, Hematology, cardiology, neuropsychiatry, rare disease and immunology Looking for candidate from Mumbai location Candidate should have Pharma background Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.
Description Sr Biostatistician Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Description Clinical Trial Manager II (Mumbai Location) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities minimum 2 Years of project mgt experience. Should have global pharma experience Candidate from Mumbai location preferred. Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation Track study progress and ensure alignment with project milestones, client deliverables, and budget, providing regular updates to stakeholders Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability Qualifications: Bachelor's degree in a related field (e.g., life sciences, clinical research) Minimum of 3 years of experience in clinical trial management or a related field In-depth knowledge of clinical research processes and regulations Strong project management and organizational skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Proficiency in using clinical trial management software and tools Certifications: Certified Clinical Research Professional (CCRP) or equivalent certification preferred Necessary Skills: Strong analytical and problem-solving skills Attention to detail and accuracy Ability to manage multiple projects and priorities simultaneously Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Clinical Trial Management job family at the P22 level are responsible for overseeing the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities. Individuals in these roles collaborate closely with the principal investigator, serve as liaisons between research subjects, client teams, investigators, and clinic operations teams, and meticulously plan logistics and resource usage. These roles require tracking study progress in alignment with project milestones, client deliverables, and budget, while ensuring compliance with applicable regulations globally and by region. Impact and Contribution Roles within the Clinical Trial Management job family at the P22 level significantly impact the success of clinical trials by ensuring that all aspects of the study are meticulously planned and executed. Individuals in these roles contribute to the design, implementation, and delivery of processes, programs, and policies, leveraging their in-depth knowledge and skills within the professional discipline. By managing processes and potentially directing the work of lower-level professionals, these roles ensure that clinical trials are conducted efficiently and effectively, ultimately contributing to the advancement of medical research and the development of new treatments. Core Focus . Overseeing the development and coordination of Phase 1 clinical research studies . Collaborating with principal investigators and serving as liaisons between various stakeholders . Planning logistics and resource usage for clinical trials . Tracking study progress in alignment with project milestones, client deliverables, and budget . Ensuring compliance with global and regional regulations . Contributing to the design, implementation, and delivery of processes, programs, and policies . Managing processes and potentially directing the work of lower-level professionals
Description Project spl Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Planning, directing, creating, and communicating clinical study timelines, ensuring that all milestones are met and that the project stays on track Gathering input from cross-functional teams, including clinical, regulatory, and data management, to create comprehensive plans for timely deliverables Ensuring consistency of clinical study processes across trials by standardizing procedures and implementing best practices Overseeing and resolving operational aspects of clinical trials, including addressing any issues that arise during the study and ensuring that all activities are conducted in compliance with SOP, GCP, and specific country regulations Selecting sites and vendors for clinical trials, negotiating contracts, and managing relationships to ensure high-quality and timely delivery of services Preparing clinical trial budgets, monitoring expenditures, and ensuring that the study remains within budget Monitoring progress of clinical trials, tracking key performance indicators, and following up with team members and line managers to address any deviations from the plan Implementing and preparing the clinical development strategy as outlined by the clinical teams, ensuring alignment with overall project goals and objectives Developing trial recruitment strategies, including identifying target populations, creating recruitment materials, and monitoring enrollment progress Qualifications: High school diploma or equivalent required Associate's degree or higher in a related field preferred Minimum of 3 years of experience in clinical project management or a related field Strong understanding of clinical trial processes and regulations Experience with SOP, GCP, and country-specific regulations Certifications: Certification in Clinical Project Management or related field preferred Good Clinical Practice (GCP) certification preferred Necessary Skills: Excellent organizational and time management skills Strong communication and interpersonal skills Ability to work effectively in a team environment Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) Attention to detail and problem-solving skills Ability to adapt to changing priorities and work under pressure We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Project Management at the S11 level are responsible for planning, directing, creating, and communicating clinical study timelines. These roles gather input from cross-functional teams to create plans that help the team produce deliverables on schedule. Individuals ensure consistency of clinical study processes across clinical trials, overseeing and resolving operational aspects in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. This includes site and vendor selection, preparing clinical trial budgets, and ensuring studies are conducted within clinical trial protocols. The roles involve monitoring progress and following up with team members and line managers when issues develop. Additionally, individuals implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies. Impact and Contribution Individuals in these roles significantly impact the success of clinical trials by ensuring that all aspects of the study are conducted efficiently and effectively. By creating and communicating clear timelines and plans, they help the team stay on track and meet deliverables on schedule. Their oversight of operational aspects and adherence to SOP, GCP, and country regulations ensures the integrity and quality of the clinical trials. Their contributions to site and vendor selection, budget preparation, and strategy implementation are crucial for the smooth execution of clinical studies. Their ability to monitor progress and address issues promptly helps maintain the momentum of the trials and supports the overall clinical development strategy. Core Focus . Planning, directing, creating, and communicating clinical study timelines . Gathering input from cross-functional teams to create plans for timely deliverables . Ensuring consistency of clinical study processes across trials . Overseeing and resolving operational aspects of clinical trials . Adhering to SOP, GCP, and specific country regulations . Selecting sites and vendors for clinical trials . Preparing clinical trial budgets . Monitoring progress and following up with team members and line managers . Implementing and preparing the clinical development strategy . Developing trial recruitment strategies
Description Accounts Payable Coordinator I (T&E) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities The Expense Report Auditor will join a team who service the expense reporting needs of Syneos Health. This position is responsible for applying Syneos Travel Policy, Client Travel Policies, and Business Conduct Standards while performing a variety of expense report and auditing functions. Most tasks will involve processing and auditing expense reports while promoting a customer service environment by responding effectively to employee inquiries in a prompt, accurate, and professional manner. Duties may include, but not limited to: Job Responsibilities: Audit selected expense reports and related receipts in accordance Travel and Expense Policy and Business Conduct Standards and approve for payment. Collect, analyze, and interpret information to assess and conclude on each assigned audit area. Prepare clear and concise documentation to adequately support all audit area conclusions and findings. Monitor and complete problematic expense reports that are in a pending status waiting for additional research and resolution. Review previous audit annotations, reports, approvals, and additional on-file information. Regularly monitor and respond to Expense Reporting voicemail and email. Respond to a high volume of employee inquiries in a prompt, accurate, and professional manner. Correctly answer employee questions regarding system issues, Travel Policy, and Business Conduct Standard reimbursement guidelines. Assist in identifying improvement opportunities and shares best practices within department. Assist in identifying potential partnerships between Expense Reporting and the various functional areas and business units throughout the Company. Cross train to perform back up functions for higher-level accounting clerks as directed or assigned. Produce required daily, weekly, and monthly reports relating to expense report auditing. Qualifications: Bachelor's degree required (Preferably in Commerce) Required 1-2 years of Travel & Expense process and Expense audit experience. Preferred to have experience on any expense tool like Concur / I-Expense/Workday etc. Expense audit experience is a preference Customer service experience Strong oral and written communication skills Proficient at Microsoft Excel and PowerPoint Ability to perform day-to-day functions with limited supervision ability to interact comfortably with individuals from various business units. Good analytical skills and a strong attention to detail. Impeccable organization skills, strong interpersonal skills and the flexibility to handle multiple tasks simultaneously. Strong Customer Relation Skills. Strong Math Aptitude. Time Management Skills. Able to work independently and as part of a team. Problem solving ability. Flexible and able to adapt to shifting priorities and responsibilities in a dynamic and changing environment. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.