Associate Data Manager

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.