Senior Manager, Study Operations Lead
IND - 2028 Takeda Innovations India Private Limited
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Job summary
The Senior Manager, Study Operations Lead at Takeda leads the Evidence Generation Study Operations team, ensuring compliant and timely support across FMV, contracting, documentation, and study lifecycle activities.
You will establish operating rhythms, capacity planning, quality checks, escalation pathways, and clear handoffs between the GCM team and Global Evidence Generation stakeholders, while mentoring Operations Enablement Leads.
Qualifications
- A degree in a scientific, medical, life sciences, pharmacy, public health, business operations, health economics, or related discipline is required; an advanced degree is a plus.
- 7+ years of related work experience; 4+ years in biopharma preferred, including evidence generation operations, clinical or study operations, HEOR operations, Medical Affairs operations, or contract and vendor operations.
- 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.
- Experience with platforms such as iEnvision Research Module, Veeva Vault, ERP or procurement tools, or equivalent systems is preferred.
- Strong operational problem-solving, stakeholder management, process standardization, quality oversight, and escalation skills.
- Fluent English is required; additional languages are advantageous.
Responsibilities
- 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.
Skills
Education
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Job description
The Senior Manager, Study Operations Lead leads the Evidence Generation Study Operations team oversees operational execution across fair market value process support, study documentation, study close-out, non-site-based and site-based study support, contracting coordination, and operational records management. The role ensures accurate, timely, compliant, and traceable operational support while enabling Global Evidence Generation and cross-functional partners to retain responsibility for strategic judgment, final approvals, scientific interpretation, and exception decision-making.
The Senior Manager, Study Operations Lead provides day-to-day leadership for Evidence Generation Operations Enablement Leads supporting study operations and site-based activities.
The role establishes operating rhythms, capacity and prioritization practices, quality checks, escalation pathways, and clear handoffs between the GCM team and Global Evidence Generation stakeholders.
The Senior Manager also oversees operational documentation, FMV process execution, contracting coordination, repository governance, reporting, team development, and continuous improvement across the study lifecycle.
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.
- A degree in a scientific, medical, life sciences, pharmacy, public health, business operations, health economics, or related discipline is required; an advanced degree is a plus.
- More than 7+ years of related work experience and more than 4 years of biopharmaceutical industry experience are preferred, including experience in evidence generation operations, clinical or study operations, HEOR operations, Medical Affairs operations, or contract and vendor operations.
- 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.
- Experience with platforms such as iEnvision Research Module, Veeva Vault, ERP or procurement tools, or equivalent systems is preferred.
- 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; additional languages are advantageous.
Amongst our benefits are:
- Competitive Salary + Performance Annual Bonus
- Flexible work environment, including hybrid working
- Comprehensive Healthcare Insurance Plans for self, spouse, and children
- Group Term Life Insurance and Group Accident Insurance programs
- Health & Wellness programs including annual health screening, weekly health sessions for employees.
- Employee Assistance Program
- 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
- Broad Variety of learning platforms
- Diversity, Equity, and Inclusion Programs
- No Meeting Days
- Reimbursements – Home Internet & Mobile Phone
- Employee Referral Program
- Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days)
- Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time
- Locations IND - Bengaluru - Research and Development Worker Type Employee Worker Sub-Type Regular Time Type Full time
- Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time
- Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time
- Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time
Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day. As an organization, we are committed to our cloud‑driven business transformation and believe the ICCs are the catalysts of change for our global organization. Takeda is an industry‑leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda‑ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.
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