Senior Data Management Specialist

2 days ago


Mumbai, Maharashtra, India Tata Consultancy Services Full time

Job Overview

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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.">
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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.">
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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.">
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About Tata Consultancy Services

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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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