Manager, Evidence Generation Study Design & Execution Lead
- Compensation
- Not disclosed
- Location
- Bengaluru, Karnātaka, India
- Work setup
- Hybrid
- Seniority
- Lead
- Employment
- Contract
- Experience
- Not specified
- Category
- Design
- Posted
Skills
Must have
- 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,
- 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.
Full description
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Job Description
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.