Assoc Clin DB Validation Mgr

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 Good 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 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).

Qualifications

• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology  Req

• 4- 6 years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 6+ yrs Req

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