Senior Data Management Specialist
2 days ago
Job Overview
">The Tata Consultancy Services is seeking an experienced Senior Data Management Specialist to join our team.
Estimated Salary Range: ₹1,200,000 - ₹1,800,000 per annum
Job Description
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- Read and understand protocol requirements to incorporate data points into specifications effectively.">
- Maintain transparency with the study team regarding timelines and potential delays' impact on eCRF development schedules.">
- Collaborate with Data Managers in study discussions, contributing valuable insights and expertise.">
- Lead and facilitate eCRF Design Meetings, ensuring smooth decision-making processes.">
- Document decisions and issues by creating backlog IDs in Project Binders during eCRF Design meetings.">
- Develop eCRF screens as per eCRF specifications in Veeva Studio, showcasing strong technical skills.">
- Configure SDV/SDR, Safety, and Coding within the Veeva CDMS tool, enhancing data management capabilities.">
- Review edit check specification documents for clarity, ensuring consistency and appropriateness based on e-CRF designs.">
- Program new study-specific checks, Protocol Deviation checks, Email Checks as per edit check specifications, demonstrating proficiency in Veeva Rules.">
- Validate and perform developer-level testing, guaranteeing high-quality results.">
- Provide UAT details to the Validation Team and Study Data Manager, promoting seamless collaboration.">
- Complete all activities detailed in relevant sections of the Developer Checklist, demonstrating exceptional organizational skills.">
- Forward Go Live/Training email details to the Study Data Lead (SDL) for inclusion in Go-Live emails.">
- Review and promote SDS, Annotated eCRF, TandE, Blank eCRF, etc., files in the eTMF system, ensuring efficient data management.">
- Confirm all required documents in the eTMF system and Project Binder within Veeva, maintaining data integrity.">
Post-Go Live Changes
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- Review change control forms and understand requested changes, applying logical reasoning.">
- Analyze the impact of change requests and suggest effective methods for handling changes.">
- Perform eCRF screen changes in Veeva as requested, utilizing appropriate methods.">
- Unit test eCRF screen changes and edit checks in the Veeva CDMS, ensuring accuracy.">
- Update/ create study-specific rules as per specification updates in Veeva, leveraging knowledge of Veeva Rules.">
- Implement feedback from execution of test scripts, applying a customer-centric approach.">
- Review changes in PPT environments for existing/new, frozen/locked subjects, maintaining data consistency.">
- Complete all activities detailed in relevant sections of the Post-Go-Live Checklist, showcasing exceptional time management skills.">
Generic Responsibilities
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- Perform and/or initiate comprehensive data management tasks related to database design, programming, validation, and data transfers.">
- Conduct quality control procedures for relevant activities, upholding the highest standards.">
- Provide Clinical Data Management teams with technical expertise, promoting knowledge sharing.">
- Maintain good communication and working relationships with DM teams, fostering a collaborative environment.">
- Perform tasks/activities communicated by customers, SDMs, or Alliance Managers, demonstrating adaptability.">
- Create/review/update Data Management Plan documents, ensuring accurate information.">
- Attend/conduct telephone conferences/meetings as required, showcasing excellent communication skills.">
- Adequate adherence to SOPs/Regulatory requirements/project-specific guidelines, maintaining regulatory compliance.">
- Escalate identified unresolved issues to customers/SDMs/Alliance Managers, demonstrating problem-solving skills.">
- Provide inputs/status reports on a monthly basis during the project lifecycle, promoting transparency.">
- Propose process improvements proactively, driving continuous improvement.">
- Share experience/lessons learned through knowledge transfer, enhancing team performance.">
About Tata Consultancy Services
">Tata Consultancy Services (TCS) is a global IT services company that provides innovative business solutions to clients across various industries. We are committed to delivering high-quality services that meet the evolving needs of our clients.
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