Clinical Research Job at Sanofi | Life Sciences Candidates, Apply Now
Sanofi Business Operations (SBO) invites applications for a Clinical Project Assistant (CPA) to join their team in Hyderabad. This essential Clinical research job focuses on the setup, administration, and quality control of the electronic Trial Master File (eTMF) and adherence to ICH GCP guidelines. If you have 3+ years of experience in clinical R&D document management and are seeking a rewarding Sanofi career, this high-impact life sciences job is your opportunity to drive tactical deliveries globally.
- Position: Clinical Project Assistant (CPA)
- Location: Hyderabad
About The Company
Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India, established to centralize processes and activities supporting Specialty Care, Vaccines, General Medicines, and R&D functions globally. SBO reduces reliance on external providers and leverages talent to build internal expertise.
Role Focus: Providing support for the setup and administration of the electronic Trial Master File (eTMF) and relevant clinical operations tools.
Key Responsibilities
The CPA is an integral part of the study team, ensuring that administrative and compliance tasks are executed promptly.
- eTMF Management: Provide support for eTMF setup to closure, including collection, archiving, uploading, and ensuring quality control for new and existing sites.
- Project Administration: Project execution, reporting, tracking progress against timelines and milestones.
- Documentation Control: Draft, update, and maintain key study-related documentation (SOPs, manuals, training guides) and ensure proper content accessibility in study portals.
- Financial & Compliance: Provide support in budgetary tracking and site payments, perform file review, and support internal/external audits.
- Stakeholder Engagement: Serve as a point of contact between the operations team and stakeholders, updating site metrics and engaging with Clinical Project Leaders (CPLs) and site staff.
Essential Qualifications and Expertise
Success in this Clinical research job requires a strong understanding of regulatory and technological requirements:
Education & Experience
- Education: A bachelor’s degree in life sciences or a related field.
- Experience: 3+ years of experience in Clinical research & development, including clinical trial eTMF document management experiences.
- Knowledge: Understanding of ICH GCP guidelines and clinical trial methodologies required.
Core Skills
- eTMF Management: Excellent eTMF management skills.
- Communication: Excellent written and oral communication skills and effective relationship management.
- Technical: Competent with Microsoft Office products and comfortable with emerging technologies.
This Sanofi career opportunity offers a focused Clinical research job in Hyderabad, pivotal to ensuring global regulatory compliance. If you possess the required experience in eTMF management and GCP guidelines, take the first step in your transformative life sciences job journey by applying now to pursue progress and discover the extraordinary with Sanofi.
