Premier Research is a leading clinical research organization (CRO) helping biotech, medtech, and specialty pharma companies bring life-changing therapies to market. We focus on innovative medicines, devices, and diagnostics, ensuring our work directly impacts patient lives.
Our culture is Built for Biotech™—empowering employees with flexibility, growth opportunities, and a collaborative environment where your voice matters.
Job Details
- Position: Data Coordinator – DM
- Job ID: R5245
- Location: Bangalore, India (Hybrid)
- Employment Type: Full-time
- Posted: Recently
Detailed Job Description
Key Responsibilities:
✔ Database Testing & Maintenance – Assist in testing clinical databases (DBs) and ensure data integrity.
✔ CRF & Data Review – Verify Case Report Forms (CRFs) and listings comply with protocols.
✔ Query Management – Generate and resolve data discrepancies with internal/external teams.
✔ User Acceptance Testing (UAT) – Test edit checks and DB updates.
✔ Documentation – Prepare CRF Completion Guidelines (CCGs), Data Management Plans (DMPs), and reports.
✔ External Data Reconciliation – Align external data (e.g., lab/Safety data) with clinical DBs.
✔ Trial Master File (TMF) Support – Submit documents and perform QC activities.
✔ Lead & Safety Review – Act as Lead Data Coordinator or Safety Reviewer on studies.
Skills & Tools:
- Experience with CDMS (Medidata Rave, Calyx EDC, etc.)
- Strong attention to detail in data QC & discrepancy resolution
- Knowledge of clinical trial protocols & regulatory standards
Eligibility Criteria
✅ Education: Bachelor’s/Master’s in Life Sciences or related field.
✅ Experience: 2-4 years in Clinical Data Management (CDM) or clinical research.
✅ Technical Skills: Proficiency in EDC systems, data reconciliation, and TMF.
Benefits & Culture
✨ Career Growth – Skill development & leadership opportunities.
✨ Work-Life Balance – Hybrid work flexibility.
✨ Impactful Work – Contribute to life-saving medical innovations.
✨ Inclusive Culture – Your ideas shape our success.
