
Sun Pharma is inviting applications from qualified Pharmacy and Science professionals for the position of Data Coordinator within its Clinical Data Management operations at Sun House, Mumbai. This role oversees clinical study documentation, User Acceptance Testing (UAT), discrepancy management, and database lock activities.
Position Summary
- Designation: Data Coordinator
- Company: Sun Pharma
- Job Location: Sun House, Mumbai
- Functional Area: Clinical Data Management (CDM) / Clinical Research
- Application Deadline: September 30, 2026
Core Responsibilities
- Study Start-Up Documentation: Author and review core start-up documents, including eCRF Completion Guidelines, Data Management Plans (DMP), Serious Adverse Event (SAE) Reconciliation Plans, and Clinical Coding Plans.
- Testing & Validation Specifications: Draft Edit Specification Documents (ESD), Test Plans, and Data Entry Guidelines; execute screen design UAT and edit check UAT in CDMS according to ESD.
- Data Cleaning & Discrepancy Handling: Manage clinical data queries, review automated system flags, verify discrepancy resolution, and support Data Managers with User Requirement Specifications (URS) for Interactive Web Response Systems (IWRS).
- Trial Reconciliation & Study Closeout: Facilitate timely completion of SAE reconciliations and database lock activities.
- Filing & Compliance: Compile, update, and perform QC on Master Data Management Files and the Electronic Trial Master File (eTMF) for regulatory audits and inspections; prepare final Data Management Reports.
Candidate Eligibility & Skills
- Education:
- Minimum Requirement: Bachelor’s degree in Pharmacy or Science (B.Pharm / B.Sc.).
- Preferred: Master’s degree / Post-Graduate in Pharmacy or Science (M.Pharm / M.Sc.).
- Experience: Minimum 5+ years of hands-on experience in the Clinical Data Management domain within a Pharmaceutical company or CRO.
- Key Competencies: Strong command of validation plan development, CDMS/IWRS environments, trial master file quality control, and clinical query workflows.
