Clinical data management
2 weeks ago
- Develop and review Case Report Forms (CRFs) / electronic CRFs (eCRFs) in collaboration with clinical and biostatistics teams.
- Design and validate clinical trial databases using CDM systems (e.g., Medidata Rave, Oracle InForm, REDCap, Veeva CDMS).
- Create and maintain data management plans (DMPs), edit check specifications, and data validation guidelines.
- Manage and monitor data entry, query generation, and data cleaning processes.
- Perform ongoing data validation to ensure data quality and consistency.
- Review external data transfers (e.g., lab, PK/PD, ECG, imaging data) for integration into the clinical database.
- Conduct data reconciliation and discrepancy management.
- Oversee serious adverse event (SAE) reconciliation and ensure safety data consistency.
- Coordinate database freeze and lock activities according to project timelines.
Job Types: Full-time, Permanent, Fresher
Pay: ₹318, ₹651,401.74 per year
Benefits:
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
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