Senior Manager, Study Operations Lead

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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.

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. Were not just transforming our company; were 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

IND - Bengaluru

Employee

Regular

Full time