Sanofi is a global biopharmaceutical company committed to improving healthcare outcomes worldwide. With a strong focus on innovation, Sanofi specializes in developing treatments for patients across various therapeutic areas, including Specialty Care, Vaccines, General Medicines, and more. Our Sanofi Business Operations (SBO) in Hyderabad plays a pivotal role in centralizing processes and supporting global operations.
Job Title: Clinical Project Assistant
Location: Hyderabad, India
Job Type: Permanent, Full-time
Posted On: February 13, 2025
Closing Date: February 20, 2025
Key Responsibilities:
As a Clinical Project Assistant (CPA) at Sanofi, you will play a critical role in supporting the Registries team and ensuring the smooth execution of clinical trials. Your responsibilities will include:
- eTMF Management:
- Set up and administer the electronic Trial Master File (eTMF) in compliance with Good Clinical Practices (GCP) and company SOPs.
- Ensure proper classification, quality control (QC), and timely upload of documents.
- Maintain TMF inspection-readiness and oversee archiving processes.
- Administrative Support:
- Assist in project management activities, including scheduling, milestone tracking, and budget monitoring.
- Prepare meeting minutes, correspondence, and project-related materials.
- Collaboration & Coordination:
- Work closely with Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site staff to ensure timely completion of administrative tasks.
- Support onboarding of new team members and manage system access.
- Compliance & Training:
- Track e-Training compliance for project teams.
- Ensure adherence to ICH-GCP guidelines and local regulatory requirements.
About You:
Experience:
- Minimum 3+ years in clinical research & development, with hands-on experience in eTMF document management.
- Strong understanding of ICH-GCP guidelines and clinical trial methodologies.
Education:
- Bachelor’s degree in Life Sciences or a related field.
Technical Skills:
- Proficiency in Microsoft Office and emerging technologies.
- Excellent attention to detail and methodical approach to task prioritization.
Soft Skills:
- Exceptional written and oral communication skills.
- Ability to maintain confidentiality and build effective relationships with stakeholders.
Languages:
- High proficiency in written and spoken English.
Why Join Sanofi?
At Sanofi, we believe in creating a diverse and inclusive workplace where everyone has the opportunity to thrive. We are committed to providing equal opportunities regardless of race, color, religion, gender, or disability. By joining our team, you will be part of a global organization dedicated to making miracles happen through better medications, better outcomes, and better science.
