CLINICAL DATABASE VALIDATION MANAGER

Job title : Clin DB Validation Manager

Experience: 10+ Years of experience,

Location : Pan India

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 ...