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