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 Ma...