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 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 strong Customer relationships.

Qualifications
• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
• 6- 8 years of relevant clinical DB Testing experience in CDMS Platforms  and total exp being 8+ yrs Req

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Experience Level

Senior Level