260 Clinical Development Jobs - Page 6

Job Type- Fresher or Internship level Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. Responsibilities: 1. Assist in Protocol Development: Collaborate with the clinical research team to contribute to the development and review of clinical trial protocols. 2. Site Identification and Selection: Participate in the process of identifying and selecting clinical trial sites by conducting feasibility assessments. 3. Regulatory Compliance: Support the team in ensuring regulatory compliance throughout the clinical trial process. Assist in the preparation and submission of regulatory documents to appropriate health authorities. 4. Site Initiation: Assist in the initiation of clinical trial sites by coordinating site training activities and ensuring that all necessary documentation is in place. 5. Monitoring and Data Collection: Work closely with clinical research associates and investigators to monitor and collect data during the clinical trial. Assist in ensuring data accuracy, completeness, and adherence to protocol. 6. Adverse Event Reporting: Contribute to the process of monitoring and reporting adverse events, ensuring compliance with regulatory requirements. 7. Study Close-Out: Participate in the close-out activities of clinical trials, including the collection of essential documents and finalizing study reports. 8. Collaboration and Communication: Work collaboratively with cross-functional teams, including clinical operations, data management, and regulatory affairs. Communicate effectively with investigators, site staff, and study sponsors. 9. Documentation and Record Keeping: Maintain accurate and up-to-date documentation of all activities performed during the internship. Contribute to the development and organization of the trial master file. 10. Learning and Development: Actively engage in learning opportunities provided during the internship to enhance knowledge of clinical research processes and industry regulations. Qualifications: Currently enrolled in a Bachelor's or Master's degree program in a related field (e.g., Life Sciences, Pharmacy, Nursing, etc.). Excellent communication and interpersonal skills. Detail-oriented with strong organizational and time management abilities. Ability to work independently and as part of a team.

PRA Health Sciences is looking for Contract Analyst I to join our dynamic team and embark on a rewarding career journey Review and analyze contracts, agreements, and legal documents to ensure compliance with company policies, standards, and applicable laws and regulations Identify and assess risks associated with contract terms, conditions, and obligations Collaborate with legal, procurement, and other relevant departments to ensure contract accuracy and completeness Negotiate contract terms and conditions, seeking favorable outcomes for the organization Assist in the development and maintenance of contract templates and standard operating procedures Conduct research on contract-related topics and provide guidance and recommendations based on industry best practices Maintain contract databases and repositories, ensuring accurate and up-to-date records Support contract administration activities, including contract amendments, renewals, and terminations Coordinate with internal stakeholders and external parties to facilitate contract execution and implementation Monitor contract compliance and performance, identifying and addressing any deviations or issues Provide contract-related training and guidance to internal teams as needed Stay informed about changes in relevant laws and regulations that may impact contract management practices Contribute to process improvement initiatives to streamline contract management workflows Assist in the resolution of contract disputes and conflicts

Contract Analyst I - India, Bangalore - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development . What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Site Specialist II - Office Based - India ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Site Specialist II to join our diverse and dynamic team. As a Site Specialist II at ICON, you will play a key role in maintaining critical clinical systems, supporting site activation activities, and contributing to the smooth delivery of trials through effective technical coordination, system management, and regulatory compliance. What you will be doing Manage and support ICON s Investigator Database across production, development, and test environments, ensuring performance and system readiness. Provide application support by implementing, configuring, and testing enhancements and new releases, working closely with end users and IT teams. Resolve user issues and service requests via ServiceNow, manage user access, and maintain system and training documentation. Support the Investigator Survey Tool and ensure successful integration with ICON systems, including Salesforce. Collaborate with Site Partners to facilitate site activation, ensuring timely collection and tracking of regulatory and start-up documentation in accordance with ICH/GCP and local regulatory requirements. Your profile Experience in application support, technical operations, or system administration within clinical research, life sciences, or healthcare. Prior experience working with Salesforce systems , including managing user access, troubleshooting, and maintaining data integrity. Strong problem-solving skills and the ability to communicate effectively across cross-functional teams and global stakeholders. Knowledge of regulatory processes related to clinical trial start-up and site activation, including documentation and TMF compliance. Working knowledge of ICH/GCP guidelines, country-specific regulations, and service management tools such as ServiceNow. #LI - KT1 What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Site Specialist II - Office Based - India We are currently seeking a Site Specialist II to join our diverse and dynamic team. As a Site Specialist II at ICON, you will play a key role in maintaining critical clinical systems, supporting site activation activities, and contributing to the smooth delivery of trials through effective technical coordination, system management, and regulatory compliance. What you will be doing Manage and support ICON s Investigator Database across production, development, and test environments, ensuring performance and system readiness. Provide application support by implementing, configuring, and testing enhancements and new releases, working closely with end users and IT teams. Resolve user issues and service requests via ServiceNow, manage user access, and maintain system and training documentation. Support the Investigator Survey Tool and ensure successful integration with ICON systems, including Salesforce. Collaborate with Site Partners to facilitate site activation, ensuring timely collection and tracking of regulatory and start-up documentation in accordance with ICH/GCP and local regulatory requirements. Your profile Experience in application support, technical operations, or system administration within clinical research, life sciences, or healthcare. Prior experience working with Salesforce systems , including managing user access, troubleshooting, and maintaining data integrity. Strong problem-solving skills and the ability to communicate effectively across cross-functional teams and global stakeholders. Knowledge of regulatory processes related to clinical trial start-up and site activation, including documentation and TMF compliance. Working knowledge of ICH/GCP guidelines, country-specific regulations, and service management tools such as ServiceNow.

Senior Investigator Payment Coordinator - India, Chennai - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an Senior Investigator payments coordinator to join our diverse and dynamic team. The Sr IPC will Liaise with all other ICON departments such as Clinical, PTS, IT, Finance, legal and contracts to ensure payment queries are speedily resolved . The candidate will have a successful background of Clinical trial payments experience. What You Will Be Doing: Support Investigator Payments team with set up and maintenance of ICON s investigators payments as appropriate. Relationship Building: Utilize your exceptional relationship-building skills to collaborate effectively with both internal and external partners daily, fostering strong connections that facilitate financial processes. Client Relationship Management: Balance client relationships, ensuring their satisfaction and addressing any concerns promptly. Support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract Review payments in line with site contracts and visit data to ensure sites are being paid in a timely accurate and efficient manner and escalate delays/ issues appropriately Set up, organize and maintain clinical study/ IPG and supporting documentation as appropriate. Work with team lead/supervisor as required to quality check /review work completed by internal IPG staff and other departments Review all site contracts and accurately set up the proposed payees and budget schedule as governed by the signed Investigator contract. Ensure ICON s reputation for excellence is carried through and maintained throughout all IPG administrative processes and highlight areas for improvement as needed Your Profile: 4-5 years of experience within a similar role within Clinical trial payments. Outstanding Excel skills, if you have Oracle Financials that is preferred. Demonstrate knowledge of site & study level reconciliations. Knowledge of general accounting principles would also be a plus. Strong attention to detail and accuracy skills with the ability to coordinate and multitask What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

Senior Investigator Payment Coordinator - India, Chennai - Hybrid, Office-Based We are currently seeking an Senior Investigator payments coordinator to join our diverse and dynamic team. The Sr IPC will Liaise with all other ICON departments such as Clinical, PTS, IT, Finance, legal and contracts to ensure payment queries are speedily resolved . The candidate will have a successful background of Clinical trial payments experience. What You Will Be Doing: Support Investigator Payments team with set up and maintenance of ICON s investigators payments as appropriate. Relationship Building: Utilize your exceptional relationship-building skills to collaborate effectively with both internal and external partners daily, fostering strong connections that facilitate financial processes. Client Relationship Management: Balance client relationships, ensuring their satisfaction and addressing any concerns promptly. Support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract Review payments in line with site contracts and visit data to ensure sites are being paid in a timely accurate and efficient manner and escalate delays/ issues appropriately Set up, organize and maintain clinical study/ IPG and supporting documentation as appropriate. Work with team lead/supervisor as required to quality check /review work completed by internal IPG staff and other departments Review all site contracts and accurately set up the proposed payees and budget schedule as governed by the signed Investigator contract. Ensure ICON s reputation for excellence is carried through and maintained throughout all IPG administrative processes and highlight areas for improvement as needed Your Profile: 4-5 years of experience within a similar role within Clinical trial payments. Outstanding Excel skills, if you have Oracle Financials that is preferred. Demonstrate knowledge of site & study level reconciliations. Knowledge of general accounting principles would also be a plus. Strong attention to detail and accuracy skills with the ability to coordinate and multitask Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

ROLE SUMMARY: The medical director provides Clinical Development leadership and expertise on clinical trials, including overseeing the design, conduct, and analysis. The medical director works closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, and patient advocacy groups. ROLE RESPONSIBILITIES: Study-level Clinical Development Leadership Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives. Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring. Lead peer-to-peer interactions with investigators. Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities. Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team. Strategic Guidance, Clinical Insights & Interpretation Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders. Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans. QUALIFICATIONS: Medical degree (MD) Relevant clinical or industry experience considered 2-5 years industry experience Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Ability to travel to relevant international scientific congresses and internal team meetings 3-6 times per year Work Location Assignment: Hybrid Work Location Assignment: Hybrid At Pfizer we care about our colleagues wellbeing and offer a range of great benefits for them, including: Paid parental leave Access to Health & Wellness apps Career Growth Experiences program Recognition & rewards program Paid volunteer days Life Insurance Benefits Pfizer Learning Academy access to top content providers Access to flu vaccines & skin checks Options to purchase additional leave Salary packaging & novated lease options *Benefits listed may vary depending on your position and location and may be subject to change. Pfizer Australia and New Zealand s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies. If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager. Medical #LI-PFE

Description. Sr Regulatory Consultant (Portfolio Management, EU mkt). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Minimum 5 years of experience in the European regulatory market.. Must have experience of end-to-end portfolio management within the EU region; global exposure is highly desirable.. Strong expertise in regulatory planning and strategy, including dossier preparation for filings, project management, labeling, and development of regulatory processes and procedures.. Hands-on experience with CTD modules 1 through 4, with a deep understanding of regulatory requirements and documentation standards.. Responsible for day-to-day contribution to project teams and projects.. Acts as a representative of the GRAS regulatory department with other departments.. Contributes technical expertise to proposals and assists with Business Development initiatives.. Understands project budgets, scope of projects, allocated hours, and tracks compliance.. Interacts with internal and external personnel, clients, and technical experts on projects.. Conducts regulatory research on projects as needed.. Provides operational advice to clients.. Prepares consulting reports under guidance.. Arranges, leads, and reports on client meetings.. Contributes to regulatory agency meetings.. Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.. Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.. Acts as a resource for technical knowledge.. Participates in quality improvement efforts to increase overall operational efficiency.. Contributes to the building of the regulatory systems and infrastructure needed for GRAS.. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry eventssuch as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.. Provides internal training in appropriate areas of expertise to other Departments.. May act as a Line Manager to a small team, dependent on the location.. Qualifications. BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. PhD preferred.. Moderate regulatory, pharmaceutical/medical device related experience.. Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP/PMP an advantage.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management skills.. Problem-solving and decision-making skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. 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.. http://www.syneoshealth.com. 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.. Show more Show less

Coding (Open end coding & Branding) and Quality checks on Excel. Prepare code frame as per responses and send for approval to client. Performing quality checks at various levels of projects to maintain standard of quality with accuracy. Monitoring the progress of the project in field/checking for documents/coordinating with client service contact and project manager for project status/requirements. Acknowledging projects from the clients. Ensure the project is delivered with error free output and meeting the TAT (turnaround time). Prepare the feedback report for the project and analyse on the basis of accuracy, and efficiency. Creation of Code frames by reviewing previous wave code frames, if available, or else creating them from Scratch and getting those approved for Research team. Timely coding the interim data and keeping the Open-end coding of Survey data up to date. Understanding the Healthcare terminologies. Qualifications 1. Person should be able to read English and understand medical terms 2. Hands on with computer applications like MS office ( word / excel) 3. Good communication 4. A science graduate ( B pharma, BSc Biology / biotech , BTech Bio etc

Description Sr Statistical Programmer SDTM, ADAM & TLFs Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were 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 and sponsor requirements Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines allvariables to be accepted by peer review and sponsor/requestor with little rework, Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others, 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, Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted, 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, Transfers deliverables, Performs other work-related duties as assigned, Minimal travel may be required Qualifications Should have an experience of 5+ years in Clinical Statistical programming with expertise in end-to-end programming (SDTM, ADAM & TLGs), Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience, Extensive programming experience in SAS or other required software, preferably in a clinical trial environment, Excellent written and verbal communication skills, Ability to read, write, speak and understand English, 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, 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 Medical Writer (Redaction) Syneos Healthis 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, youll 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 WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Authoring andQuality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: o Clinical study documents or any other documents for regulatory submission i-e , clinical study reports, patient narratives, clinical summaries etc for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) o Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process 2 Additional Activities Completion of Internal and Client specific training Assist in mentoring and training of team members depending upon project requirement(s) Qualifications We are looking for 4-8 yearsexperience medical writer who will be involved in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) Candidate should be well versed with all the related regulations, perform quality review, client communication and management, Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials gov and for various other clinical registries will be added advantage Resource should understand & comprehend protocol and clinical study report from disclosure perspective Good understanding of Clinical Trial Disclosure fundamentals is expected Qualification Requirement Educational qualifications: A minimum of a scientific graduate degree in life sciences, Good knowledge of regulatory requirements or guidance pertinent to the service line, Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines Clear written and verbal communication skills Good knowledge of basic computer applications, e-g MS Word/ PowerPoint/ Excel, will be required, Person should understand & comprehend protocol and clinical study report from disclosure perspective, Good understanding of clinical trial disclosure fundamental Core competencies for this role include ability to demonstrate: o Analytical capabilities with scientific and clinical data o Professional working environment o Ownership of the work allocated o Commitment to highest quality outputs, including high attention to detail o Enthusiasm and pro-activity o Effective team working Ability to build rapport/ relationships with project-specific client colleague 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, 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,

SBO Manager (HEVA) will be functionally aligned to Global HEVA business partners (BPs)/Global HEVA Evidence Synthesis lead and will support execution of multiple activities Manage assigned Evidence Synthesis projects in the assigned portfolio to plan and generate robust health economics and value based evidence to maximize the value propositions from both a global and US perspective working within the Market Access tripod by working with Global HEVA BPs/Global HEVA Evidence Synthesis lead Work with Global HEVA BPs/Global HEVA Evidence Synthesis lead to manage and execution of quality research projects, economic models, trial design recommendations and other activities in support of programs/products as required Support HEVA BPs/Global HEVA Evidence Synthesis lead in the planning, design, implementation, and completion of innovative evidence-based research programs that are consistent with program/product strategies. The research programs developed by Global HEVA BPs will provide appropriate evidence and/or tools to be used for internal decision making and for external audiences at product launch and over product life cycle Collaborate with Global HEVA BPs/Global HEVA Evidence Synthesis lead to seek opportunities to innovate HEVA value identification, evidence generation and dissemination process/plan to increase the relevance and impact of HEVA evidence to ensure reimbursement decisions optimal access Create complex and specialized strategic content without supervision Develop and maintain TA expertise Develop and review content created by HEVA associates Coach HEVA associates People: (1) Develop and maintain effective relationships with key internal stakeholders including Medical Affairs, Clinical Development, Commercial and Market Access (2) Constantly assist and provide effective feedback to HEVA associates (senior or junior) in developing knowledge and sharing expertise (3) Work effectively with global HEVA teams across various time zones Performance: (1) Manage the HEVA evidence generation projects in collaboration with Global HEVA BPs: Develop research plan to support pre-launch, launch and post-launch evidence for investigational and marketed drugs; Evidence generation plan includes burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, development and analysis of patient-reported outcomes; Provide strategic support with individuals and institutions, which may serve as resources for evidence generation purpose, etc; Work closely with the HEVA product lead to manage and execute research studies to support the clinical, economic and humanistic value of products; Studies include but are not limited to burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, and patient-reported outcomes; Lead development of core value dossier (CVD) and AMCP dossiers under the strategic direction of Global HEVA BPs Process: (1) Develop complex HEVA strategic evidence material (2) Build expertise in the field of HEVA for the assigned Therapeutic area (3) Manage core HEVA strategic evidence generation processes, templates, and products across the portfolio in accordance to the scientific and value messages aligned with CVD, the US AMCP dossier, and HEVA contributions as appropriate to other submissions (4) Accountable for adherence to the evidence generation guidelines and other standards relevant to HEVA evidence generation processes at SBO (5) Leverage advanced training delivery tools & techniques thereby enhancing the effectiveness of training delivery (6) Design an overall plan of action basis end-customers feedback & improve course content and delivery Stakeholder: (1) Work closely with HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs and Market Access global or local teams in regions/areas to identify evidence generation and dissemination needs and assist in developing assigned deliverables (2) Liaise with these teams to prepare relevant & customized deliverables and ensure milestones and timelines are on track for assigned the projects About you Experience : 8+ years of experience in HEOR for the pharmaceuticals industry, CRO consultancy or academia. Soft skills : Demonstrate effective communication, organizational and interpersonal skills; Able to work effectively as part of a multidisciplinary global teams; Able to work independently, but in concert with the direction provided by their management, in accordance with defined functional policies and precedents, budgetary guidelines, company values, ethics and applicable law; Ability to handle multiple projects across different therapeutic areas; Ability to work we'll in a cross-functional team; Understanding of the disease environment and the evolution of the market access landscape and implications for the business; Proven track record working successfully in a project/matrix-oriented environment; Excellent communication skills and ability to understand and present complex information in digestible ways for internal (eg senior management) and external audiences; Strong team spirit, sense of transversality, multicultural awareness and ability to drive matrix teams Technical skills : Strong analytical skills to translate clinical and economic information and messages into payer evidence strategies; Understands reimbursement decisions to determine value drivers and how evidence is used in decision making and how it impacts various payers (eg, providers, patients, health systems); Knowledge of methods and principles of health economics, health technology assessment (HTA) reviews Education : Advanced degree in life sciences/pharmacy/similar discipline or medical degree Languages : Excellent knowledge of English language (spoken and written)

Job Description Jubilant Bhartia Group Jubilant Bhartia Group is a global conglomerate founded by Mr Shyam S Bhartia and Mr Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services Jubilant Bhartia Group has four flagships CompaniesJubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited Currently the group has a global workforce of around 43,000 employees, About Jubilant Biosys Jubilant Biosys Ltd is a part of the Jubilant Pharmova family of companies with R&D centres in India and business offices in Asia and North America With our global reach, Jubilant Biosys provides comprehensive drug discovery services and contract research servicesfrom target discovery to candidate selection and with flexible business models (FFS, FTE and risk shared)in partnership with leading worldwide healthcare companies, With a clear scientific focus in oncology, metabolic disorders, central nervous system (CNS) diseases, pain and inflammation, Jubilant Biosys has rapidly emerged as a leading collaborator for pharmaceutical and biotechnology companies worldwide In each of these therapeutic areas, Jubilant Biosys has developed a deep level of expertise in discovery informatics, computational chemistry , medicinal chemistry, structural biology , biology,in-vivo,in-vitromodels and translational sciences Combined with strong clinical development and manufacturing capabilities from other Jubilant subsidiaries, Jubilant Biosys has risen as a fully integrated contract research organization in India and headquartered at Bengaluru with end-to-end solutions, Our ability to be the preferred collaborator in the drug discovery domain is sustained by our commitment to comply with and continually improve our quality systems and to provide the following services: Contract Research Preclinical CRO Drug Discovery Virtual Screening Protein Crystallization Toxicology &In-vitroADME Medicinal Chemistry Synthetic & Developmental Chemistry Pharmacology Jubilant Biosys collaborates with the worlds leading pharmaceutical, biotech companies, academic institutions and research foundations, Find out more about us at jubilantbiosys, The Position Organization : Jubilant Biosys Designation & Level: RA / SRA (S1/S2/S3/S4) Location: Greater Noida Department: Analytical Key Responsibilities Having exposure of 1-8y in analytical chemistry (HPLC/LCMS/NMR or purification) Interaction with synthetic team and problem solving skills, Should be able to handle the respective instrument Knowledge of instrumental technique with its application Should be able to handle routine analysis independently on respective instrument, Experience in method development on HPLC/LCMS will be desirable but not necessary Maintenance, cleaning, documentation and calibration of analytical instruments, Maintain laboratory as safe working place, Person Profile Qualification: - Sc (Analytical Chemistry) Experience: - 2 years of relevant experience Jubilant is an equal opportunity employer All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances,

As a Senior Principal Statistical Programmer, you will have the opportunity to work with advanced technical solutions such as R, Shiny, and SAS, allowing you to lead asset teams and mentor junior staff effectively. In this role, you will contribute to global assets across a variety of therapeutic areas, shaping strategic decisions in statistical programming. Your responsibilities will include leading the trial or asset programming team as the Lead Statistical Programmer, ensuring that asset and trial delivery aligns with established timelines and quality standards. You will perform programming activities at both trial and asset levels, including the development of SDTM and ADaM datasets and the creation of specifications. Additionally, you will develop and validate analytical outputs in accordance with the Statistical Analysis Plan and create datasets for integrated analyses like ISS or ISE. You will also be responsible for executing ad-hoc programming activities based on internal and external requests. Actively contributing to statistical programming initiatives, you will support process improvements and innovation while providing expert advice, guidance, and training to trial and asset teams, fostering the development of your colleagues' skills. Who are you: BSc or MSc (in a numerate discipline preferably in Mathematics, Statistics or Computer Science) Proven success in a Statistical Programming role within clinical development at a pharmaceutical or biotech company, or at a CRO, equivalent to a minimum of 9 years directly relevant experience. Experience in an international environment is a plus. Advanced skills in R and SAS Full familiarity of CDISC SDTM and ADaM standards (including specifications, Define.xml, and reviewers guide) and underlying concepts. Strong understanding of processes related to clinical development programs, Experience in leading e-submission processes is beneficial. Demonstrated ability to manage assets effectively, ensuring timely delivery and quality outcomes Ability to provide solutions for complex programming challenges and evaluate alternatives to identify optimal solutions.

Vendor Masterfile Associate - Hybrid - Chennai (Office based) ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Vendor Masterfile Associate to join our diverse and dynamic team. As a Vendor Masterfile Associate, you will play a crucial role in managing vendor data, ensuring accuracy and compliance, and driving efficient procurement processes. Your attention to detail and organizational skills will be instrumental in maintaining our vendor masterfile integrity and optimizing vendor management practices. What you will be doing: Managing vendor data in the masterfile system, ensuring accuracy and completeness. Reviewing and verifying vendor information to ensure compliance with company policies and procedures. Communicating with internal stakeholders and vendors to gather necessary information and resolve discrepancies. Driving procurement processes by updating vendor records, including pricing and payment terms. Generating reports and performing data analysis to identify trends and opportunities for improvement in vendor management. Your Profile: Bachelor s degree in business administration, Finance, Accounting, or related field preferred. Previous experience in vendor management, data entry, or a related field is a plus. Strong attention to detail and accuracy in data entry and management. Excellent communication and interpersonal skills. Proficiency in Microsoft Excel and other data management tools. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Investigator Payment Associate, Chennai ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Summary: Responsible for ensuring timely and accurate processing, payment and reconciliation of creditor invoices, investigator payment requests and employee expense claims. What You Will Be Doing: Timely and accurate processing of AP invoices Management of all documentation in line with statutory requirements Reconciliation of Investigator accounts Resolution of issues with investigators invoices Participation in re-engineering projects as needed Your Profile: Minimum 1.5+ years experience in a multi-national Accounts Payable function Computer Literate - Intermediate to advanced Excel skills Good accounting systems knowledge (Oracle an advantage) Bachelors degree in Commerce Excellent communication skills What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Quality Audit Coordinator serves as the central point for all sponsor, regulatory, supplier, and internal audits across the company s eClinical solutions. The role safeguards continuous inspection readiness by organizing evidence, managing logistics before, during, and after each audit, and collaborating with departments across the entire Organization. Success is measured by complete and accurate audit files, on-time CAPA closure, and ongoing process improvements that streamline future inspections. KEY TASKS & RESPONSIBILITIES Pre-audit coordination assists with scheduling audits, confirm audit scope, assembles document packages, schedule interviews with subject-matter experts, and prepare on-site or virtual audit rooms. Live audit support serve as primary scribe, manage real-time document requests, track question/response logs, and controls the flow of materials to auditors. Post-audit follow-up compile meeting minutes, distribute observation summaries, assists in maintaining a findings tracker, and coordinate timely CAPA responses with owners. Maintain audit documentation keep electronic folders and QMS trackers current, version-controlled, and compliant with retention requirements. Support internal quality audits schedule, prepare, and close routine internal audits. Capture and verify records document audit interviews accurately and circulate for stakeholder confirmation. Facilitate cross-functional readiness ensure the various business units have evidence and answers prepared in advance. Assist with vendor audits assist with coordinating assessments of third-party eClinical service providers and monitor follow-up actions. Improve audit processes recommend and implement tools or workflow changes that reduce audit-prep time and strengthen documentation integrity. Update SOPs and work instructions related to audit management and inspection readiness. Perform additional duties as assigned to enhance the Quality Management System and maintain continuous inspection readiness. Education & Experience Bachelor s degree in a related field is preferred 3-5 years of experience working in a pharmaceutical industry is preferred. Knowledge of clinical trial terminology and process. Knowledge of GxP quality standards, applicable regulations, and software development risks. Professional Skills Professionalism, confidentiality, and organization. Excellent writing and typing skills. High level of organizational skills and record-keeping. Ability to work effectively under critical deadlines. Robust communication skills and attention to detail. Technical Skills Ability to pull reports or extract data when needed. Ability to easily learn various software applications. Experience with Qualio or other type of QMS tool Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Client Services Associate I - India, Bangalore - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Client Service Associate I to join our diverse and dynamic team. As a Client Service Associate I at ICON, you will play a pivotal role in delivering exceptional customer service, managing client relationships, and ensuring the smooth operation of client projects. What you will be doing Acting as the client s main point of contact throughout the lifetime of a Contract/Change Order drafting to execution, successful candidates must possess exceptional communication and customer service skills. Drafting project budgets/budget amendments, and Change Order documents. Assisting in the development and implementation of client service strategies to enhance customer satisfaction and retention. Collaborating with internal teams to ensure client needs are met and projects are executed effectively and efficiently. Providing administrative support, such as maintaining client records, preparing reports, and managing correspondence. Your profile Bachelor s degree in Life Science, business administration, or a related field preferred. Previous experience in customer service, client relations, or a similar role is advantageous. Strong interpersonal and communication skills , with the ability to build and maintain positive relationships with clients and colleagues. Excellent organizational skills and attention to detail , with the ability to manage multiple tasks and priorities effectively. Excellent working knowledge of MS Excel and MS Word . What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Compliance Associate will assist the Sr. Compliance Manager with relevant laws, regulations, and internal policies. Responsibilities will also include managing the Vendor Intake process, conducting vendor audits, and guiding other department personnel thru the vendor management process. KEY TASKS & RESPONSIBILITIES Assist the Sr. Compliance Manager with key compliance-related initiatives such as SOC2, ISO, and other related areas. Manage the Vendor Intake process by working with departmental leaders to assess / re-assess vendors as required. Provide backup support as required to the overall Quality and Compliance team. Respond to co-worker questions regarding compliance regulations and industry best practices. Represent Vendor Management in Audits and ongoing process improvements. Serve as a document coordinator owning the maintenance of Compliance documentation -SOP, WIs, Templates, Forms, ensuring content accuracy and adherence to standards. Other duties as assigned Education & Experience BS degree or job-related equivalency preferred Experience in Quality and Compliance, or similar administrative role Experience and knowledge of compliance regulations and industry best practices Experience working in a fast-paced environment preferred Professional Skills Excellent knowledge of English Strong understanding of business goals and standards for customer service Strong Presentation skills Excellent decision-making skills Strong interpersonal and communication skills Team player and Collaborator that can handle multiple tasks simultaneously in a fast-growing company. Technical Skills Strong time-management and organizational skills Problem-solving skills Analytical skills Adaptable to change Attention to detail Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Investigator Payment Associate - India, Chennai - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an Investigator Payment Associate to join our diverse and dynamic team. As an Investigator Payment Associate at ICON, you will play a crucial role in facilitating investigator payments, ensuring compliance with regulations, and reviewing the financial aspects of clinical trials. What you will be doing: Processing investigator payments accurately and timely according to study protocols. Maintaining documentation and records related to investigator payments in compliance with regulatory requirements. Discussing with internal teams to resolve payment discrepancies and address inquiries from investigators. Assert the development and implementation of processes to streamline investigator payment procedures. Assisting in the preparation of financial reports and analysis related to investigator payments. Your profile: Bachelor s degree in finance, Accounting, or related field. 1-2 years of experience in finance or accounting roles, preferably in the pharmaceutical or clinical research industry. KNwledge of regulatory requirements related to investigator payments (e.g., Sunshine Act, FMV). Strong attention to detail and ability to work accurately in a fast-paced environment. Proficiency in Microsoft Excel and financial software (e.g., SAP, Oracle). Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Commitment to Diversity and Inclusion: Accessibility and accommodation Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Job Title: Associate Global Development Scientist Director, Late Development Oncology Global Career Level: E Introduction to role: Are you ready to make a difference in the world of oncology? The Global Development Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field based liaisons, and site personnel. The Global Development Scientist and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. This includes providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA). The Global Development Scientist may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience. As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements. Accountabilities: Clinical Development Responsibilities - Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. - Assists in the implementation of protocols and interactions with vendors and CROs, working closely within cross-functional team. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials). Assists in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites. Serves as contact with vendors and CROs regarding medical/clinical science issues. - Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc., and write any necessary queries to be communicated to sites to ensure data accuracy and completeness of the assigned study. - Participate in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program. Ensure updates to safety information are shared with cross-functional study team. Support review of safety narratives. - Supports preparation of abstracts, manuscripts, publications, and poster presentations of clinical study findings and results throughout the life cycle of the assigned study or product, as applicable. Supports medical affairs activities, payer and reimbursement activities. - Assists with drafting assigned sections of clinical reports, dossiers, and other documents. - Support Data Management in the build of the CRF and all associated instructions and plans (e.g., CRF completion instructions and Data Review Plan). Technical Skills - Basic understanding of drug development from molecule to market and demonstrates knowledge of scientific methodology in the design, conduct, and description of clinical research at a study level. - Ability to understand and contribute to the drafting of documents used throughout the clinical study lifecycle, such as site initiation materials, registration documents, protocols, and presentations. Demonstrates solid understanding of methodology in the design, conduct, and interpretation of clinical research. Outstanding attention to detail and outstanding written communication skills. - Serves as medical/clinical science representative on study team and collaborates cross-functionally on applicable deliverables during study life cycle (e.g., the protocol, CRF, data listings, TLF, CSR etc.) - Ability to analyze and summarize clinical results. Support creation of and review of clinical slides for internal and external meetings. Essential Skills/Experience: - Required Life Sciences degree or equivalent - PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience - Industry or academic experience in drug development required. - Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research. - Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals. - Ability to grow and maintain a high level of expertise in oncology therapeutic area. At AstraZeneca, we are driven by a mission to transform cancer treatment through innovative approaches like novel biomarkers, AI, novel endpoints, and cutting-edge trial designs. Our collaborative environment empowers you to take smart risks and challenge norms while working alongside top experts globally. With one of the broadest oncology pipelines in the industry, youll have opportunities to work with new drugs that truly improve patient outcomes. Ready to join us on this exciting journey? Apply now to be part of our transformative team! 12-Jun-2025 17-Jun-2025

Typical Accountabilities: Coordinate SD system activities and collection of SD metrics. Facilitate maintenance of study delivery system data and implementation of system enhancements. Develop reporting tools for SD Systems. Maintain an awareness of the external Process and Technology environment to identify opportunities for Study Delivery Delivers centrally managed services across drug projects (e.g. document management support, Clinical Trial Transparency) Ensures Business Continuity for SD Processes and Systems Facilitates dynamic sharing of Study Delivery knowledge and establishment of best practice; Ensure and develop effective communications and aid in consistent communication within Study Delivery Participates in change initiatives relating to Study Delivery Meets high SHE standards and legal obligations Demonstrates willingness to take on any level project activity consistent with current or past experience in support of study delivery Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration Typical People Management Responsibility (direct / indirect reports): Approximate number of people managed in total (all levels) - 0 What is the global remit? (how many countries will the role operate in?): 2 or 3 countries at a minimum of 40% of time Education, Qualifications, Skills and Experience: Essential: University degree in biological science, health related field, licensed registered nurse or equivalent experience; Significant experience in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes; Working knowledge of clinical and pharmaceutical drug development process and associated government regulations, ICH and GCP; Demonstrated aptitude for process and technology; Demonstrated ability to work collaboratively in a team environment as well as independently; proven ability to facilitate team building and team work; Excellent written and verbal communication skills in English; Excellent negotiation, collaboration, interpersonal, problem solving and conflict resolution skills; Demonstrated ability to set and manage priorities, resources, goals and project initiatives; Demonstrated leadership ability in a team environment as well as ability to function independently; Ability to travel both domestic and international; Customer Focused; Performance Driven Desirable: Clinical study delivery operational experience; Ability to lead and contribute to non-drug projects, with internal and external partners, that supports worldwide and local studies across different phases of drug development and different therapy areas; Proven Conceptual and Analytical thinking; concern for standards and willingness to learn from others; Understands concept of Business Continuity Planning.; Invites input from each person, shares ownership and visibility; creates a climate of collaboration; Demonstrates operational expertise in risk management and contingency planning; Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of AZ and SD systems/software in an e-enabled environment; Has in depth knowledge of GCP, AZ Procedural documents, as they pertain to Study delivery systems and processes; Positive change management skills, individually, team and business seeing change as an opportunity to improve performance and add value to the business; Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement Key Relationship to reach solutions: Internal (to AZ or team): Study Delivery personnel; Study delivery team personnel; Clinical Development personnel; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate External (to AZ): External service providers; Marketing Company personnel 13-Jun-2025 15-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com . Alexion participates in E-Verify.

Position Purpose: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer s products and to meet regulatory requirements. Primary Responsibilities: Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately. Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness / listedness / labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly. Review case criteria to determine the appropriate workflow for case processing. Write and edit the case narrative. Generate reports, ensuring adherence to regulatory compliance timelines. Determine appropriate case follow-up, requesting follow-up letters when appropriate. Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation. Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database. Consistently apply regulatory requirements and Pfizer policies. Qualifications (i. e. , preferred education, experience, attributes): Masters degree in healthcare profession (ie, Pharmacy, Dentistry, Nursing etc). 1-3-years experience in pharmacovigilance/ related domains. Work Location Assignment: Hybrid Medical #LI-PFE