Sanofi: Advance Your Career in Clinical Research Documentation
Summary:
Sanofi, a global biopharmaceutical leader, is seeking talented and driven individuals to join our growing R&D team in Hyderabad. We have two exciting opportunities: R&D eTMF Document Specialist and R&D TMF Support Team Lead. These roles are critical to ensuring the accuracy, completeness, and regulatory compliance of our clinical trial documentation. If you possess a strong background in life sciences, a keen eye for detail, and a passion for contributing to the advancement of healthcare, we encourage you to apply. These positions offer excellent opportunities for career growth, global exposure, and the chance to make a real difference in the lives of patients.
1. R&D eTMF Document Specialist – Hyderabad
Role Overview:
As an R&D eTMF Document Specialist, you will play a crucial role in managing Trial Master File (TMF) documentation for our clinical studies. Your primary responsibility will be to ensure that all documentation is accurate, complete, and inspection-ready, adhering to ICH-GCP guidelines and Sanofi’s Standard Operating Procedures (SOPs). You will work closely with global study teams, TMF managers, and Contract Research Organization (CRO) partners to maintain a high level of TMF quality and compliance.
Key Responsibilities:
- Manage and maintain TMF documents within the eTMF system (Veeva Vault experience is a plus) according to ICH-GCP guidelines and Sanofi SOPs.
- Perform metadata entry, indexing, document Quality Control (QC), and file reviews to ensure accuracy and completeness.
- Conduct Expected Document List (EDL) checks to track TMF completeness and identify any missing documents.
- Coordinate corrections and revisions of documents as needed, resolve documentation queries, and manage user tasks within the eTMF system.
- Support audits, inspections, and TMF retrieval activities by providing timely and accurate documentation.
- Collaborate effectively with study teams, Study Managers (SMs), Clinical Operations Study Leads (COSLs), Clinical Operations Study Clinical Leads (COSCLs), and external vendors.
- Contribute to TMF process improvements, system testing, and training initiatives.
- Track and report TMF metrics and deviations to identify areas for improvement and ensure compliance.
Qualifications:
- Bachelor’s degree in Life Sciences or Pharmacy.
- Proven experience working with eTMF systems; Veeva Vault experience is highly preferred.
- Solid understanding of ICH-GCP guidelines and clinical research processes.
- Exceptional attention to detail and organizational skills.
- Strong English communication skills, both written and verbal.
- Ability to work effectively in a cross-functional team environment and adapt to a fast-paced work environment.
Benefits:
- Opportunity to work in a dynamic global R&D environment.
- Gain valuable exposure to TMF inspection-readiness processes and regulatory documentation requirements.
- Excellent career growth potential within clinical operations and TMF management.
- Be part of an inclusive and diversity-driven workplace culture.
2. R&D TMF Support Team Lead – Hyderabad
Role Overview:
As the R&D TMF Support Team Lead, you will be responsible for overseeing the TMF support team in Hyderabad. Your primary focus will be to ensure the delivery of high-quality documentation outcomes, maintain inspection readiness, and promote efficient operations across global clinical studies. You will play a key role in leading, mentoring, and developing your team to achieve excellence in TMF management.
Key Responsibilities:
- Lead and mentor TMF support staff in the Hyderabad hub, providing guidance, training, and performance feedback.
- Manage TMF Quality Control (QC) processes, document migrations, and inspection-readiness activities to ensure compliance and accuracy.
- Collaborate with global TMF and R&D functional leads to align strategies and ensure consistent TMF practices.
- Drive process improvements, innovation, and team development initiatives to enhance efficiency and effectiveness.
- Manage budgets, participate in hiring processes, oversee training programs, and track team performance metrics.
- Support audits, legal requests, mergers and acquisitions (M&A) activities, and system upgrades related to TMF.
- Foster a change-agile and compliant work culture within the team, encouraging continuous improvement and adherence to regulations.
Qualifications:
- Bachelor’s degree in Life Sciences or a related field.
- 3–5 years of industry experience with demonstrated leadership experience or potential.
- Comprehensive knowledge of Good Clinical Practice (GCP), drug development processes, and documentation guidelines.
- Strong team management, negotiation, and conflict resolution skills.
- Excellent ability to work effectively across global time zones and with diverse teams.
Benefits:
- Opportunity to take on a leadership role in a global R&D TMF environment.
- Accelerated career growth potential into operations management.
- Lead high-impact documentation functions and contribute to the success of clinical trials.
- Gain exposure to global TMF, regulatory, and audit teams.