Clinical Project Assistant
Location: Hyderabad, India
Job Type: Full-Time | Permanent
Overview
Sanofi is seeking a Clinical Project Assistant (CPA) to provide administrative and operational support for clinical trials. The CPA ensures proper setup, documentation, and quality control of trial data while maintaining compliance with Good Clinical Practices (GCP), ICH guidelines, and company SOPs. This role is ideal for individuals with experience in clinical trial document management and cross-functional collaboration.
About the Role
As part of Sanofi Business Operations (SBO), the CPA will support the clinical study team throughout the trial lifecycle, from startup to closeout. This role bridges project operations and stakeholders, ensuring smooth execution, accurate documentation, and timely reporting.
Key Responsibilities
Clinical Project Support
Support the setup, administration, and maintenance of electronic Trial Master File (eTMF), IMPACT CTMS/eSTRA, and related clinical tools.
Assist in project setup from initiation to closure, including site document collection, archiving, and quality control.
Maintain study portals, version-controlled documents, and e-training records.
Track project timelines, milestones, and provide progress reports.
Documentation & Compliance
Draft, update, and maintain key study documentation, SOPs, manuals, and training guides.
Conduct file reviews and support internal/external audits to ensure document completeness and regulatory compliance.
Support budget tracking and site payments as needed.
Stakeholder Engagement
Serve as a point of contact between study teams, stakeholders, and site staff.
Collaborate with Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and cross-functional teams.
Prepare meeting minutes, status updates, and stakeholder communications.
People & Performance
Assist onboarding new team members, providing access to tools and orientation.
Conduct routine quality checks on study documents.
Promote effective collaboration and adherence to project processes.
Experience & Skills
3+ years in clinical research or clinical trial document management.
Knowledge of ICH-GCP guidelines and clinical trial methodologies.
Strong eTMF management skills and familiarity with emerging technologies.
Proficient in Microsoft Office and comfortable with digital tools.
Effective communication and relationship management skills with cross-functional teams.
Education
Bachelor’s degree in Life Sciences, Pharmacy, or related field.
Languages
High proficiency in written and spoken English.
Why Join Sanofi
This role provides the opportunity to contribute to impactful clinical research, develop expertise in clinical operations, and collaborate with global teams. Sanofi promotes diversity, equity, and inclusion, providing an environment that supports professional growth and meaningful contributions to healthcare.
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