Lead Data Manager

Job Title: Lead Data Manager

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Mandatory Requirements

• Experience in leading clinical studies (Study Conduct & Close-Out)
• PAN & DOB required for Employee Profile creation
• Graduation is compulsory

Lead Data Manager

Key Responsibilities

1. Possess full understanding of EDC systems, study documentation, and protocols to effectively execute and oversee data management activities for multiple trials.
2. Demonstrate strong knowledge of clinical drug development, CDISC standards (SDTM, CDASH), data confidentiality, and technology platforms used in clinical data management.
3. Support development of trial-specific documents such as clinical trial protocols and participate actively in operational trial team meetings.
4. Serve as the

   primary point of contact (POC)

   for all trial-related data management discussions.
5. Develop mock CRFs for EDC build, release and amend databases, prepare data transmission agreements, maintain study status in EDC, and prepare Trial-Specific Instructions for CRF completion.
6. Create data management and data review plans, prepare data validation specifications, manage queries, perform SAE and external vendor reconciliations, and support development of the CQM plan.
7. Support execution of data listing programs ensuring consistency, quality, and completeness of patient data.
8. Set up and test SDTM specifications, schedule SDTM transformation runs, perform study data snapshot requests, and generate define.xml files with SDTM programmers.
9. Deliver adhoc, interim, and final datasets, ensuring quality and integrity of post-delivery data.
10. Upload, maintain, and approve required trial documents in the Trial Master File (TMF).
11. Identify, highlight, and escalate project risks and issues to the Project Lead in a timely manner.
12. Provide oversight and perform QC activities for end-to-end data collection processes.
13. Track deliverables, resolve study issues, monitor metrics, and ensure zero open queries at database lock.
14. Guide and mentor new team members on trial processes, documents, and onboarding activities.
15. Ensure team compliance with TCS SOPs and maintain mandatory training documentation.
16. Offer technical expertise to trial teams to maintain stability and consistency in trial requirements.
17. Train Data Management team members on processes, procedures, and applications.
18. Perform any additional tasks as required.
19. Complete all assigned LOS trainings on time.
20. Demonstrate strong leadership, proactive communication, risk management, negotiation, analytical thinking, and ability to prioritize tasks.