Manager, Evidence Generation Operations Enablement (non-site based)

Takeda · Bengaluru

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 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. 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.

Time Type

Full time

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