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 testing activities in the team, e.g. proactive and accurate resource planning, planning for deliverables, identifying risks (if any) and escalate such risks to the Supervisor.
• Conduct Quality Reviews as applicable.
• Review individual project financial performance and communicate issues to the appropriate stakeholders. Ensure adherence to study budgets.
• Serve as primary point of contact for Internal Customers on testing deliverables.
• Provide justification for and perform direct negotiations with Internal Customers, e.g., timelines, financial, process, resources.
• Develop and maintain robust Customer relationships.