Manager, Evidence Generation Study Design & Execution Lead

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

The Manager Evidence Generation Study Design & Execution Lead provides non-site-based study operations support across intake and triage study progress documentation close-out tracking fair market value support cross-functional coordination investigator-initiated and collaborative research contracting support evidence package upload and vendor artifact storage. The role delivers consistent high-quality and traceable operational execution across repeatable evidence generation workflows enabling Global Evidence Generation teams to focus on scientific strategy study prioritization final decisions and stakeholder engagement.

About the Role

The Manager Evidence Generation Study Design & Execution Lead coordinates study operations activities across multiple non-site-based study types. The role manages intake completeness review logistics study documentation close-out packages FMV records contracting materials vendor artifacts and evidence package archival. The role works with Global Evidence Generation Legal Compliance Finance Procurement local operating companies vendors and study teams escalating strategic scientific budget legal compliance or non-standard documentation questions to the appropriate owner.

How You Will Contribute

• Receive and log evidence generation collaborative research study support and contracting requests including requester asset indication region timing request type and completeness status.
• Conduct first-pass completeness checks and route requests to the appropriate Global Evidence Generation portfolio study or functional owner.
• Coordinate cross-functional synopsis and protocol review logistics including reviewer lists timelines meeting scheduling comment collation version control and action tracking.
• Escalate conflicting scientific strategic legal or compliance comments to Global Evidence Generation for resolution.
• Maintain study documentation checklists status trackers milestone updates open-action logs and repository records for assigned non-site-based studies.
• Prepare study status summaries for study leads or governance review including progress updates risks dependencies and missing documentation.
• Apply standard close-out procedures collect final study documents track vendor budget and contract close-out actions and store final close-out packages.
• Flag missing documents unresolved payments pending approvals open risks or study-specific exceptions to the appropriate owner.
• Support first-pass FMV documentation rate-table checks assumption capture and archival of FMV outcomes with contract packages.
• Prepare internal contracting initiation packages for investigator-initiated research collaborative research and other non-site-based agreements including study overview intellectual property terms publication rights budget inputs and required approvals.
• Coordinate Legal or shared contracting review and track amendments renewal triggers negotiation points and contracting lifecycle milestones.
• Store vendor artifacts statements of work scorecards correspondence contract records and performance documentation with correct metadata access controls retention category and study linkage.
• Maintain traceable logs for intake review contracting close-out vendor artifacts and evidence package archival.
• Identify recurring process gaps and support improvements to templates trackers checklists and handoff materials aligned with quality and compliance requirements.
• Use approved digital automation and AI-enabled tools where appropriate to support intake documentation tracking review coordination issue identification and operational reporting while maintaining accuracy traceability privacy and human oversight.

Qualifications

• A degree in a scientific medical life sciences pharmacy public health operations health economics or related discipline is required.
• More than 5 years of related work experience and more than 2 years of biopharmaceutical industry experience are preferred including experience in evidence generation operations clinical operations HEOR operations Medical Affairs operations study coordination contract administration or vendor operations.
• Working knowledge of evidence generation study operations intake management documentation tracking study close-out and cross-functional review coordination.
• Familiarity with investigator-initiated research collaborative research contracting workflows FMV documentation Legal review routing and vendor artifact management.
• Experience maintaining audit-ready repositories trackers version histories and documentation packages.
• Strong coordination skills across Global Evidence Generation Legal Compliance Finance Procurement local operating companies vendors and study teams.
• Familiarity with iEnvision Research Module Veeva Vault document repositories procurement systems or equivalent tools is preferred.
• High attention to detail and the ability to manage multiple concurrent workstreams.
• Comfort using approved automation and AI-enabled tools for defined operational activities 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