About the job
Our Team:
Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D;, Data & Digital functions​. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ in Sanofi, globally.
The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool.
Main responsibilities:
The Central CRA serves as the primary liaison for the Principal Investigator and other site staff involved in conducting rare disease registries at the investigational site.
1. Feasibility Activities:
o Involvement in the site selection process together with the Registries Team.
2. Study Start-up Activities:




o Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
o Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
o Prepare EC cover letter and any additional materials required (if applicable)
o Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)
o Prepare the Insurance Certificate application when applicable.
o Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.
o Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)
o Assist with the upload & file of Study Start-up documentation into the eTMF.
o Ensure that all parties

📌 Central Clinical Research Associate (Hyderabad)
🏢 Sanofi
📍 Hyderabad