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 Takeda’s 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.
Job Description
The Manager, Evidence Generation Operations Enablement (non-site based) 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 Operations Enablement (non-site based) 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…