Job Title: Clinical Project Assistant (CPA)
Company: Sanofi
Location: Hyderabad, India
Job Type: Permanent, Full-time
Division/Team: Sanofi Business Operations (SBO) – Clinical Operations Support
The Clinical Project Assistant (CPA) supports clinical study execution, documentation, and administration throughout the lifecycle of clinical trials. The role ensures compliance with protocols, Good Clinical Practices (GCP), and company SOPs while coordinating with cross-functional teams and stakeholders.
1. Clinical Trial Support:
Support setup and administration of electronic Trial Master File (eTMF), IMPACT CTMS/eSTRA, and other clinical tools.
Ensure adherence to protocol, GCP guidelines, and corporate/local SOPs.
Collect, archive, and upload study documents from start-up to study closure.
Conduct quality control checks for eTMF and study documentation.
2. Project Administration:
Track project progress against timelines and milestones.
Draft, update, and maintain study-related documents, SOPs, manuals, and training guides.
Maintain study portals and update content versions as needed.
Prepare meeting minutes, status reports, and stakeholder updates.
3. Financial & Compliance Support:
Support budget tracking and site payments when required.
Assist internal and external audits, ensuring document readiness and completeness.
Maintain e-training records and monitor mandatory learning compliance.
4. Stakeholder Engagement & Collaboration:
Serve as point of contact between operations team and stakeholders.
Update site milestone data, IRB/IEC approval dates, and enrollment metrics.
Engage with Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), site staff, and cross-functional teams.
Assist in onboarding new team members, providing tools access and orientation.
5. People & Performance:
Collaborate with study teams from start-up to archiving.
Interact with CPLs, CRAs, and site staff to ensure timely completion of administrative tasks.
Maintain study documentation and conduct routine QC checks.
Education: Bachelor’s degree in Life Sciences or related field.
Experience: 3+ years in Clinical Research & Development, including eTMF document management.
Understanding of ICH-GCP guidelines and clinical trial methodologies.
Soft Skills:
Excellent written and oral communication.
Ability to maintain confidentiality of study data.
Effective relationship management with study teams and sites.
Technical Skills:
Strong eTMF management and project coordination skills.
Methodical approach to prioritization and task execution.
Familiarity with Microsoft Office and emerging technologies/mobility applications.
Understanding of local regulatory requirements.
Experience with cross-functional collaboration.
Languages:
High proficiency in written and spoken English.
Opportunity to contribute to global clinical trials and drug development.
Career growth and exposure to cross-functional teams.
Inclusive, supportive work culture with structured development pathways.
Recognition and rewards for contributions and impact.
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