Study Data Manager

TCS is hiring for Study Data Management Role!

Location - Mumbai/Hyderabad

Major Accountabilities

• Study Operational Oversight: Lead and manage a multidisciplinary cross-functional Study Team (including business owners/medics, medical writing, statistics, data management, drug supply, regulatory, safety, legal, procurement, quality, external vendors & stakeholders etc. as applicable) in the effective planning, execution, management and reporting of assigned GMA studies, NIS, RCs,

• Study Tracking, Reporting & Metrics: Track study progress, generate regular reports, and ensure timely updates of operational metrics. Preparation and presentation of Study Reporting & Metrics to various stakeholders as required.

• Risk Monitoring & Management: Identify, monitor, track and manage risks and issues, propose mitigation strategies, and escalate as appropriate in collaboration with the study’s Business Owner.

• Development & Review of Study Documentation: Coordinate and support review of key study documents such as protocols, amendments, monitoring plans, and third-party study reports, as applicable, including input to ensure operational.

Key Performance Indicators

• Timely, efficient, and high-quality delivery of assigned studies and study-related activities within budget and in compliance with quality standards

• Proactive, iterative operational planning with effective contingencies and embedded risk management mindset

• Cost effective management of budget with limited unforeseen cost overruns

• Consistent application and practice of agile leadership behavior

• Ability to foster an empowered, psychologically safe culture and environment

where all associates thrive and are working towards their fullest potential