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Study Data Manager

Tcs
TCS
5-10 years
preferred by company
10 Jan. 19, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Study Data Manager

Experience Required: 5–10 Years
Location: Mumbai or Hyderabad, India
Employment Type: Full-time
Function: Clinical Data Management / Study Operations
Industry: Clinical Research / Pharmaceuticals / Life Sciences
Apply By: 03 April 2026
Job ID: 389991


About the Role

Tata Consultancy Services (TCS) is hiring an experienced Study Data Manager to support global clinical and observational research programs. This role is responsible for providing end-to-end operational oversight of assigned studies, ensuring high-quality execution, compliance, and timely delivery within budget.

The position involves close collaboration with cross-functional stakeholders across clinical research, data management, biostatistics, medical writing, regulatory, safety, and external vendors.


Key Responsibilities

Study Operations & Leadership

  • Lead and manage multidisciplinary, cross-functional study teams, including medical, data management, statistics, regulatory, safety, quality, procurement, and external vendors

  • Oversee planning, execution, management, and reporting of assigned Global Medical Affairs (GMA) studies, Non-Interventional Studies (NIS), and Real-World/Registry studies

Study Tracking, Reporting & Metrics

  • Track study progress and operational milestones across the study lifecycle

  • Prepare, analyze, and present study-level metrics and reports to internal and external stakeholders

  • Ensure timely and accurate communication of study status, risks, and performance indicators

Risk & Issue Management

  • Proactively identify, monitor, and manage study risks and issues

  • Develop and implement mitigation strategies in collaboration with the study Business Owner

  • Escalate critical risks and deviations as per governance requirements

Documentation & Compliance

  • Coordinate the development, review, and approval of key study documentation, including protocols, amendments, monitoring plans, and third-party reports

  • Ensure operational feasibility, quality, and compliance with applicable regulations and internal standards


Key Performance Indicators

  • Timely, high-quality delivery of assigned studies within approved budgets

  • Effective operational planning with embedded risk management and contingency strategies

  • Cost-effective budget management with minimal unforeseen overruns

  • Demonstrated agile leadership and collaborative working style

  • Ability to foster a psychologically safe, high-performing team environment


Required Qualifications

  • Bachelor’s degree in Pharmacy (B.Pharm), Science (B.Sc), or Life Sciences

  • Master’s degree in Pharmacy (M.Pharm) or Science (M.Sc) preferred


Required Experience

  • Minimum 5 to 10 years of experience in clinical research, study data management, or study operations

  • Proven experience managing cross-functional teams and complex clinical or observational studies

  • Strong understanding of clinical research processes, study governance, and operational metrics


Key Skills & Competencies

  • Clinical research and study data management expertise

  • Strong stakeholder management and communication skills

  • Experience with study tracking, reporting, and performance metrics

  • Risk assessment and mitigation capabilities

  • Ability to work in matrixed, global team environments

  • Strong organizational, leadership, and problem-solving skills


Why Join TCS

TCS offers the opportunity to work on global clinical research programs within a structured, quality-driven environment. You will collaborate with diverse teams, apply agile leadership principles, and contribute to impactful healthcare and life sciences initiatives.