Study Data Manager – Clinical Research
Location: Mumbai / Hyderabad, India
Experience: 5–10 Years
Job Type: Full-Time
Job ID: 389991
About TCS
Tata Consultancy Services (TCS) is a global leader in IT services, consulting, and business solutions. With expertise across industries, TCS delivers transformative solutions to healthcare and life sciences organizations, enabling the effective management of clinical trials, patient data, and regulatory compliance.
Role Overview
The Study Data Manager will oversee the planning, execution, and management of clinical studies, including Global Medical Affairs (GMA) studies, Non-Interventional Studies (NIS), and Registries/Real-World Evidence studies (RCs). The role requires a proactive, detail-oriented professional capable of leading cross-functional study teams, ensuring data integrity, and delivering high-quality study outcomes.
Key Responsibilities
Study Operational Oversight
Lead and manage multidisciplinary study teams including medical, statistics, data management, regulatory, safety, quality, legal, procurement, drug supply, and external vendors.
Ensure effective planning, execution, monitoring, and reporting of assigned clinical studies.
Study Tracking, Reporting & Metrics
Track study progress and performance metrics.
Prepare and present study updates, reports, and operational metrics to stakeholders.
Risk Monitoring & Management
Identify, assess, and manage operational risks and issues.
Develop mitigation strategies and escalate concerns in collaboration with business owners.
Study Documentation & Compliance
Coordinate review of study protocols, amendments, monitoring plans, and third-party study reports.
Ensure compliance with clinical and regulatory standards.
Team Leadership & Culture
Foster an empowered, psychologically safe environment where team members thrive.
Apply agile leadership practices to optimize team performance.
Key Performance Indicators (KPIs)
On-time delivery of study milestones with high-quality outputs.
Effective risk management and contingency planning.
Cost-effective budget management with minimal overruns.
Agile leadership and team empowerment.
Compliance with clinical research and regulatory standards.
Qualifications
Education:
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
Bachelor of Science (B.Sc) / Master of Science (M.Sc)
Experience:
5–10 years in clinical research, data management, or related roles.
Hands-on experience managing clinical study data, cross-functional teams, and operational metrics.
Skills:
Strong understanding of clinical trial processes and data management.
Proficiency in clinical study documentation and regulatory compliance.
Excellent organizational, reporting, and stakeholder management skills.
Ability to manage risks, budgets, and timelines efficiently.
Why Join TCS
Lead critical clinical research programs impacting global patient care.
Work in a collaborative, cross-functional, and innovative environment.
Opportunity to grow professionally within life sciences and clinical research domains.
Contribute to high-impact studies while enhancing operational excellence and data quality.
Gujarat :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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New Mexico | Ciudad de México |Dubai :
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Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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Singapore |Sofia City :
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Warsaw |