6 + years of Core Clinical Data Management (CDM) experience, including 2+ years of external data handling and reconciliation (Lab & ECG). The ideal candidate should have hands-on experience with Medidata Rave EDC and be experienced in managing study activities from start-up through database lock.
Perform clinical data management activities throughout the study lifecycle, from start-up to closeout.
Drafting and review of study specific documents (DMP, eCRF completion guidelines, DRP, database design specifications, DVP
Data listing review and query management
User Acceptance Testing (UAT)
External data reconciliation (Lab & ECG)
Preparation of study-specific reports
Database freeze and lock activities
Review/ drafting of vendor data transfer agreements/specifications
Quality control (QC) of listings and closed queries




Filing and maintenance of study documentation in eTMF
Support study closeout activities and other assigned responsibilities
Ensure adherence to applicable SOPs, GCP guidelines, and regulatory requirements.
Collaborate with cross-functional teams
Perform additional duties and responsibilities as assigned.

Qualification: B. Pharm/M. Pharm/Life Sciences Graduate, Postgraduate

Additional Skills:
Experience working with global clinical trials.
Knowledge of clinical data management SOPs and regulatory requirements.
Exposure to multiple external data vendors and reconciliation processes.

📌 Associate Data Manager Faridabad
🏢 WOW Softech
📍 Faridabad