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 management plans across multiple projects/programmes. Track service performance and provide leadership to identify root cause of issues and implement remedial actions.
• Continuously look for opportunities to improve the process; work with team to develop and implement plan to re-organize and drive change across multiple projects/programme (with minimal support)
• Ensure timely follow-up and resolution of compliance issues.
• 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 Manager.
• Conduct Quality Reviews as applicable.
• Review the QIP for appropriate budget allocation and communicate if any out of scope activities are noted.
• Review individual project financial performance and communicate issues to the appropriate stakeholders. Ensure adherence to study budgets.
• Supervise implementation of new technology.
• 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.
• All responsibilities are essential job functions unless noted as nonessential (N).