PHARMAFull time
Central Clinical Research Associate
By Admin · Clinical Research & Clinical Operations
HYDERABAD (IN)ONSITEPOSTED: 11/1/2026
PHARMAFull time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE OVERVIEW
Sanofi is hiring a Central Clinical Research Associate in Hyderabad to support rare disease registry studies. The role coordinates with principal investigators and site staff and covers start-up, monitoring, data review and site-management tasks under ICH-GCP.
ROLE DEFINITION & RESPONSIBILITIES
- •Take part in site feasibility and selection with the registries team.
- •Help gather and check site documents for health-authority, ethics-committee and IRB submissions, including cover letters and insurance applications where applicable.
- •Support site contracts, budget discussions and informed-consent form customisation, and file start-up documents in the eTMF.
- •Plan and carry out site selection, initiation, routine monitoring and close-out visits remotely or on site, following the protocol, ICH-GCP, local rules and SOPs.
- •Review study data, check eCRFs for completeness, resolve queries, follow up on enrolment and keep data-management colleagues informed.
- •Check site facilities, staff training and system access, and build working relationships with investigational sites and vendors.
- •Support safety reporting and site-level quality control, analyse deviations, and help implement corrective and preventive actions with audit and inspection readiness in mind.
- •Keep trackers and databases current, contribute to TMF compliance and take part in study meetings, audits and inspections.
REQUIRED VERIFIED SKILLS
ICH-GCP
Good Clinical Practice (GCP)
ethics-committee/IRB and health-authority submissions
site monitoring visits
remote and on-site monitoring
eTMF and TMF filing
eCRF review
query resolution
source-document checks
safety reporting
root-cause analysis
CAPA
informed-consent form customisation
site contract and budget support
data-management coordination
stakeholder communication
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Sanofi Business Operations is an India-based internal resource group within Sanofi. Its purpose is to consolidate work that supports areas including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital.
TEAM SIZE: Approximately 90,000 employees
INDUSTRY: Pharmaceuticals / Biotechnology
APPLICATION ADVISORY
Highlight experience with site start-up documents, ethics-committee/IRB and health-authority submissions, and site contract or informed-consent work. Show familiarity with remote and on-site monitoring under ICH-GCP, eTMF filing, eCRF review and query resolution. Mention any work with safety reporting, CAPA, source-document checks and coordination with principal investigators, vendors or data-management teams.
SPONSORED · TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.