R&D TMF Support Team Lead – Hyderabad, India
Company: Sanofi
Job Type: Full-time
Department: R&D / Clinical Operations
Sanofi is seeking an experienced R&D TMF Support Team Lead to oversee TMF operations within the Hyderabad Hub. This role is central to ensuring inspection readiness, regulatory compliance, and high-quality delivery across all eTMF support functions. The ideal candidate will be a strong people leader with the ability to guide teams, collaborate with global functions, and drive continuous improvement across TMF-related workflows.
The position requires expertise in TMF processes, document management, regulatory expectations, and the ability to lead in a dynamic, global, and cross-functional environment.
Lead and manage the Hyderabad TMF Support team to ensure consistent delivery of high-quality outputs.
Oversee day-to-day TMF operational activities, including QC checks and document migration into the eTMF system.
Promote a culture of teamwork, accountability, performance, and continuous improvement.
Mentor, coach, and support staff in developing subject matter expertise and technical capabilities.
Work closely with global functional leads on prioritization, metrics, workflows, and performance alignment.
Build strong cross-functional relationships to support knowledge-sharing and operational consistency.
Support global initiatives related to audits, inspections, mergers, legal requests, and strategic transformation efforts.
Ensure team activities comply with health authority regulations, ICH-GCP standards, Sanofi SOPs, and internal quality requirements.
Maintain ongoing inspection readiness by ensuring completeness, accuracy, and quality of TMF records.
Stay informed on evolving TMF practices, regulatory expectations, and inspection trends.
Act as a key change agent for new technologies, system enhancements, and process improvements.
Drive adoption of innovative solutions to enhance TMF operations and overall efficiency.
Manage budgets, resource plans, and performance targets effectively.
Support talent acquisition, hiring, onboarding, and training activities.
Manage team performance reviews, goal-setting, and development discussions.
Provide strategic input to enhance TMF support services and operational excellence.
Bachelor’s degree in Life Sciences or a related field (or equivalent qualification).
Minimum 3–5 years of industry experience in clinical research, TMF management, or related areas.
Proven experience leading teams, ideally in a matrix or global environment.
Strong understanding of drug development, document standards, and regulatory guidelines.
Hands-on experience with electronic document management or eTMF systems.
Strong leadership, team management, and strategic decision-making abilities.
Ability to negotiate, influence, and resolve conflicts in a global environment.
Understanding of basic finance, HR concepts, and operational planning.
Excellent verbal and written communication skills in English.
Ability to work across time zones, cultures, and fast-paced business environments.
Demonstrated experience in process change management and continuous improvement.
Sanofi offers a future-focused environment where scientific innovation meets digital transformation. Employees have the opportunity to shape advancements in oncology, vaccines, rare diseases, and neurology while growing their own scientific and leadership capabilities. The organization is committed to diversity, equity, inclusion, and providing meaningful development opportunities for all employees.
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