Clinical Data Specialist (UAT)

Project Role: Clinical Data Specialist (UAT)

Work Experience: 3 to 6 years

Work location: Across PAN INDIA

Work Mode: Hybrid

Job Overview:

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Testing Lead and Manager.

Essential Functions :

Essential Functions

• Providing knowledge in validation tasks and performing database validation efforts to ensure delivery of high-quality databases.
• Lead database audit team.
• Accountable for overall quality and delivery of the validation effort.
• Test databases and edit specifications, which includes Creates and enters test cases within the Data Management Plan.
• Reconciling Edit Check status prefixes using the DMP reconciliation report.
• Updates the Edit check status appropriately within the Data management Plan and clinical trial database (CTDB), if applicable. Communicates issues for erroneous Edit Checks within the Data Management Plan to the programmer.
• Communicates any document update requirements or uncertainties to the Lead Data Manager.
• Understand and comply with core operating procedures and working instructions.
• Develop and maintain good communications and working relationships with CDM team. Continuously look for opportunities to improve process, work with team to implement plan to re-organize and drive change across portfolio, with minimal support. Advanced understanding of database structures. Provide support to Testing lead as required an contribute to documentation and communication with internal customers.
• May serve as back-up for Testing lead. Serve as a Subject matter expert (SME).
• Mentor new team members.
• Attend regular project meetings.
• Review of project plan and escalate issues to stakeholders. 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. Develop and maintain strong customer relationships.

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