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Job DescriptionThe 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.
About the Role
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.
How You Will Contribute
- 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.
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.
- 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.
Benefits
It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. 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)
About ICC in Takeda
- 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.
IND - Bengaluru
Employee
Regular
Full time
IND - Bengaluru - Research and Development
Employee
Regular
Full time
Locations
IND - Bengaluru
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
LocationsIND - BengaluruWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Skills Required
- Degree in scientific, medical, life sciences, pharmacy, public health, business operations, health economics, or a related discipline
- More than 7 years of related work experience
- More than 4 years of biopharmaceutical industry experience
- 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, fair market value process execution, study closeout, 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 iEnvision Research Module, Veeva Vault, ERP or procurement tools, or equivalent systems
- Strong operational problem-solving, stakeholder management, process standardization, quality oversight, and escalation skills
- Comfort using approved AI-enabled and automated tools with appropriate judgment regarding accuracy, privacy, traceability, compliance, and escalation
- Fluent English
- Additional languages
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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