Manager, Study Execution and Design Lead

Overview

Execute defined internal evidence generation study activities, including study setup support, routine analysis coordination, milestone tracking, quality review coordination, documentation, and study record archival, so that Global Evidence Generation study teams can focus on study design and strategic judgment.

What you'll do

• Input study details into relevant systems, including data inputs, analysis workflows, assumptions logs, required checkpoints, and documentation expectations.
• Execute defined internal study activities using approved processes and templates, with support from R&D, the Real-World Data Center of Excellence, or analytics partners where needed.
• Conduct routine analyses or execution tasks within agreed scope and generate draft outputs for Global Evidence Generation review.
• Track study milestones, dependencies, open questions, deviations, assumptions, limitations, and execution risks.
• Maintain study trackers, status summaries, action logs, review packages, and documentation checklists.
• Finalize execution packages and maintain study records, analysis outputs, assumptions logs, limitations, and review history.
• Ensure documentation is complete, traceable, version-controlled, and linked to the appropriate study repository.
• Perform first-pass checks for completeness, formatting, required fields, and documentation quality.
• Escalate methodology changes, scope issues, interpretation questions, data issues, quality concerns, and strategic decision points to the appropriate accountable owners.
• Coordinate with Global Evidence Generation, the Real-World Data Center of Excellence, R&D, Insights & Analytics, DD&T, local operating companies, and other study partners to resolve operational dependencies.
• Support improvements to study execution templates, trackers, checklists, and handoff materials.
• Use approved digital, automation, and AI-enabled capabilities responsibly to improve study setup, milestone tracking, documentation quality, workflow coordination, and identification of execution risks, applying appropriate human review, traceability, privacy, quality, and compliance controls.
• Identify repeatable study execution activities that may benefit from standardization or automation and contribute to continuous improvement of GCM ways of working.

What you'll need

• A degree in a scientific, medical, life sciences, pharmacy, public health, epidemiology, data science, health economics, or related discipline is required.
• More than 5+ years of related work experience and more than 2 years of experience in the biopharmaceutical industry.
• Working knowledge of the evidence generation study lifecycle, study execution support, milestone tracking, and documentation requirements.
• Ability to execute defined study tasks within approved scope and escalate methodology or interpretation questions appropriately.
• Familiarity with study systems, repositories, trackers, study reports, analysis workflows, and audit-ready documentation.
• Strong coordination skills across Global Evidence Generation study teams, the Real-World Data Center of Excellence, R&D, Insights & Analytics, DD&T, local operating companies, and vendors.
• High attention to detail and demonstrated ability to manage multiple concurrent study workstreams.
• Ability to maintain complete, traceable, version-controlled study records and execution packages.
• Comfort using approved AI-enabled and automated tools with appropriate human review, traceability, privacy, quality, and compliance controls.
• Fluent English is required.

Nice to have

• Experience in evidence generation operations, clinical or study operations, HEOR or real-world evidence operations, study coordination, analytics operations, or medical affairs operations.
• Experience supporting multiple concurrent study workstreams, maintaining study documentation, and coordinating across cross-functional partners.
• Additional languages are advantageous.

Details

• Location: Bengaluru, India.
• Employment type: Full time, Regular employee.
• Flexible work environment, including hybrid working.