Clinical Database Validation Manager

Clin DB Validation Mgr Job Overview To act as a SPOC/technical SME for all prevailing EDC platforms with respect to validation scope of activities. Play major role in facing Customer Audits, Internal QA Audits etc. Essential Functions • Attend Kick Off Meeting and regular project meetings until Study Go Live • Review Project Plan and escalate issues (if any) to applicable stakeholders and Review the QIP/UPT for appropriate budget allocation and communicate if any out of scope activities are noted. • Review ASB/ALS and Edit Specifications document provide input and escalate issues if any. • Provide project status updates on validation activities to Data Team Lead/Lead Programmers and attend all PRM meetings. • Periodic check on critical projects Documentation in eTMF • Conduct periodic Knowledge Sharing sessions across functional groups • Serve as Subject Matter Expert (SME) for validation group. • Train and mentor Testing Team Members. • Provide end to end Project Management for testin...