Assoc Clin DB Validation Mgr (Kolkata)

Assoc Clin DB Validation Mgr (Kolkata)

02 Oct
|
Iqvia
|
Kolkata

02 Oct

Iqvia

Kolkata

Job Overview
Manage end-to-end delivery of testing services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive testing expertise to testing team to provide high quality database that meet customer requirements. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Comply with Valuable Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
Essential Functions
• Attend Kick Off Meeting and regular project meetings until Study Go Live.
• Take complete responsibility for creation of Edit Checks Test Plan document and writing test cases.
• Release the Edit Checks Test Plan to the testing team to conduct testing activities.
• Review Project Plan and escalate issues (if any) to all stakeholders.
• Comprehend study protocol and share the basic requirement of protocol with validation project team.




• Perform eCRF and Time & Events QC as per QC checklist.
• Test email alerts
• Review ASB and Edit Specification document, provide input and escalate issues if any.
• Document in version history if any changes made to Edit Specifications within Test Plan during validation process.
• Request final and authorized version of documents to validate system configuration (AUL, Rights and Roles, Home page, System Settings).
• Provide project status updates on validation activities to Data Team Lead/Lead Programmers.
• Review Testing Comments Log after each cycle of testing and provide Testing Comments Log to Programmer.
• Document all testing documentation in eDMSF in a timely manner.
• Co-ordinate with internal Customers on a regular basis and establish strong Communications with them.
• Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables.
• Implement proactive quality mana

📌 Assoc Clin DB Validation Mgr (Kolkata)
🏢 Iqvia
📍 Kolkata

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