Senior Manager, Study Operations Lead

Overview

Lead the Evidence Generation Study Operations team, overseeing operational execution across FMV process support, study documentation, study close-out, study support, contracting coordination, and operational records management.

What you'll do

• Manage daily workflow, prioritization, capacity planning, and performance across Evidence Generation Operations Enablement Leads supporting study operations and site-based activities.
• Establish operating rhythms, escalation pathways, quality checks, service expectations, and handoff protocols between the GCM team and Global Evidence Generation stakeholders.
• Oversee operational execution across FMV documentation, study progress reporting, study close-out support, contracting coordination, repository updates, and operational records management.
• Maintain clear boundaries between GCM execution responsibilities and decision rights retained by authorized owners for budget approvals, FMV exceptions, study priorities, site selection, compliance, and scientific judgment.
• Oversee the FMV process execution model, including first-pass calculations, rate-table use, documentation, exception routing, and archival of outcomes with contract records.
• Coordinate with Finance, Procurement, Legal, Compliance, R&D, Global Evidence Generation, local operating companies, and vendors to resolve process gaps, routing questions, and escalation needs.
• Monitor operational risks related to scope changes, approval exceptions, documentation completeness, overdue items, and process bottlenecks, and drive corrective actions and continuous improvement.
• Oversee support for intake and triage, synopsis and protocol review coordination, feasibility, site identification and selection activities, study-progress documentation, close-out tracking, vendor-artifact storage, and investigator-initiated or collaborative-research contracting support.
• Ensure study records, status summaries, close-out packages, vendor artifacts, and evidence packages are complete, version-controlled, linked to relevant studies, and inspection-ready.
• Coach and develop Operations Enablement Leads, identify skill gaps, and support onboarding, training, capability development, and consistent performance expectations.
• Serve as the primary GCM study operations point of contact for the Evidence Generation Strategy & Operations Enablement Group Lead and provide reporting on workload, service performance, quality issues, capacity risks, and transition readiness.
• Use approved AI-enabled and automated tools, where appropriate, to support intake, FMV activities, documentation tracking, exception identification, and operational reporting while maintaining validation, traceability, data privacy, and human oversight.

What you'll need

• A degree in a scientific, medical, life sciences, pharmacy, public health, business operations, health economics, or related discipline.
• Strong understanding of evidence generation operations, study lifecycle support, contracting coordination, FMV process execution, study close-out, and repository governance.
• Working knowledge of study documentation, operational trackers, cross-functional review coordination, feasibility, and site-based study support.
• Ability to manage complex handoffs across Global Evidence Generation, Finance, Procurement, Legal, Compliance, R&D, local operating companies, and vendors.
• Experience managing teams or senior individual contributors, including workload prioritization, coaching, performance support, and capability development.
• Strong operational problem-solving, stakeholder management, process standardization, quality oversight, and escalation skills.
• Comfort using approved AI-enabled and automated tools for operational workflows, with appropriate judgment regarding accuracy, privacy, traceability, compliance, and escalation.
• Fluent English is required.

Nice to have

• An advanced degree.
• More than 7+ years of related work experience and more than 4 years of biopharmaceutical industry experience, including experience in evidence generation operations, clinical or study operations, HEOR operations, Medical Affairs operations, or contract and vendor operations.
• Experience with platforms such as iEnvision Research Module, Veeva Vault, ERP or procurement tools, or equivalent systems.
• Additional languages.

Details

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