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

Overview

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 for Global Evidence Generation teams.

What you'll do

• 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.

What you'll need

• A degree in a scientific, medical, life sciences, pharmacy, public health, operations, health economics, or related discipline is required.
• 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.
• 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.

Nice to have

• More than 5+ years of related work experience and more than 2 years of biopharmaceutical industry experience, including experience in evidence generation operations, clinical operations, HEOR operations, Medical Affairs operations, study coordination, contract administration, or vendor operations.
• Familiarity with iEnvision Research Module, Veeva Vault, document repositories, procurement systems, or equivalent tools.

Details

• Location: IND - Bengaluru.
• Employment type: Full time, Regular employee.
• Work mode: Non-site based, with flexible work environment including hybrid working.