Clinical Project Assistant
📍 Location: Hyderabad, India
🏢 Company: Sanofi Business Operations (SBO)
🕒 Job Type: Full-time
🔗 Apply Now: Sanofi Careers
About Sanofi
At Sanofi, you’ll help deliver life-changing treatments across a diverse and growing portfolio — from trusted medicines to groundbreaking innovations in immunology, diabetes, cardiovascular, and chronic disease care.
We’re leveraging AI, digital tools, and global collaboration to transform healthcare faster than ever. Join us and be part of where ambition meets impact.
About Sanofi Business Operations (SBO)
Sanofi Business Operations is an internal center of excellence based in India.
It supports Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions by:
Centralizing processes and activities
Building internal expertise
Reducing dependency on external vendors
Creating a strong, skilled global support system
Position Overview
The Clinical Project Assistant (CPA) provides comprehensive operational and administrative support for global clinical studies — ensuring efficiency, compliance, and quality throughout the trial lifecycle.
The role involves eTMF management, project coordination, document control, and cross-functional communication to support Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site teams.
Key Responsibilities
1. Study Setup & Administration
Set up and maintain electronic Trial Master File (eTMF) and IMPACT CTMS/eSTRA systems in compliance with GCP and SOPs.
Support study setup through closure, including document collection, uploading, archiving, and quality checks.
Maintain study portals, SharePoint, and tools with updated and version-controlled content.
2. Project Coordination
Track project progress against timelines and milestones.
Support budget tracking and site payments when required.
Prepare meeting minutes, reports, and stakeholder updates.
Conduct routine QC checks of study documentation.
Support internal/external audits by ensuring document readiness.
3. Team and Stakeholder Support
Collaborate with CPLs, CRAs, and site staff to complete administrative tasks.
Assist with onboarding of new team members (access setup, orientation).
Maintain training records, monitor completion rates, and ensure team compliance with mandatory training.
Serve as a communication bridge between operations teams and study stakeholders.
Update site milestones, IRB/IEC approvals, and enrollment metrics as applicable.
4. Documentation & Compliance
Draft, update, and maintain study-related documents, manuals, SOPs, and training guides.
Ensure data integrity, confidentiality, and adherence to GCP guidelines.
Perform file reviews and maintain document accuracy for audit readiness.
People, Performance & Process
|
Dimension |
Focus |
|---|---|
|
People |
Collaborate with CPLs, CRAs, and site teams from study start-up to close-out. |
|
Performance |
Maintain high-quality documentation and conduct QC reviews. |
|
Process |
Support continuous improvement and compliance with SOPs and GCP. |
|
Stakeholder Engagement |
Understand and meet internal/external stakeholder expectations. Foster cross-functional collaboration for efficient study execution. |
Qualifications
Education
Bachelor’s degree in Life Sciences or a related field.
Experience
Minimum 3+ years of experience in Clinical Research & Development, with strong exposure to eTMF document management.
Understanding of ICH-GCP guidelines and clinical trial methodologies.
Skills & Competencies
Technical Skills
Strong knowledge of eTMF management systems and CTMS tools (IMPACT, eSTRA).
Competent with Microsoft Office Suite and digital collaboration tools.
Understanding of GCP principles, local regulatory requirements, and audit readiness.
Soft Skills
Excellent written and verbal communication (English).
Strong organizational, prioritization, and time management skills.
Effective stakeholder and relationship management.
High sense of confidentiality and professionalism.
Ability to adapt to emerging technologies and manage multiple priorities.
Languages
High proficiency in spoken and written English.
Additional language (e.g., Japanese) is a plus for document review.
Why Join Sanofi?
✨ Pursue Progress. Discover Extraordinary.
Work on global clinical projects impacting millions worldwide.
Collaborate with diverse teams across regions and functions.
Experience a culture that values growth, inclusion, and innovation.
Join an organization committed to ethical science and human progress.
Diversity, Equity & Inclusion
Sanofi is an equal opportunity employer — welcoming talent from all backgrounds and identities.
We are committed to providing a workplace that embraces diversity, equity, inclusion, and accessibility.
🎥 Watch our “ALL IN” and “One Day at Sanofi” videos to explore our DE&I initiatives.
🌐 Visit: www.sanofi.com
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