Introduction
We are seeking a Project Coordinator, O2R Business and Operations to support the conduct of Evidence Generation Studies (EGS) within the Oncology Business Unit (OBU) Medical organization, with a primary focus on secondary data studies (approximately 80%) and complementary support for primary/hybrid studies (approximately 20%). This role sits within Medical Excellence, Strategy and Operations and partners closely with Study Leads from Oncology Outcomes Research Organization (O2R) and cross-functional teams. The Project Coordinator provides operational support across contracting/vendor management, systems stewardship (Veeva Clinical Vault, Airtable), documentation/TMF, and publication review and sign off coordination.
The ideal candidate works effectively cross functional team to support O2R Leads on compliant, high-quality study execution across global and local boundaries. You demonstrate strong organizational skills and attention to detail while navigating processes and multiple systems.
Responsibilities
- Study conduct support (secondary data studies ~80%; primary/hybrid ~20%)
- Partner with Study Leads to operationalize study plans and maintain milestones across systems and documentation.
- Steward data and study details in Veeva Clinical Vault (VCV), and Airtable, including milestones, country/study attributes, financial sponsors and delivery models.
- Support adherence to operational and compliance processes
- Contracting and vendor management
- Coordinate D-Code Requests, 3PRM, CDAs, RFPs, SOWs and amendments; manage Scientist.com engagements which includes onboarding new vendors, executing SOWs/Amendments; and track cycle times and approvals.
- Finance operations
- Request creation/amendment of POs; troubleshoot invoicing issues; set up and close cost centers; ensure COUPA data accuracy; reconcile spend to plan.
- Prepare and support in-house study quarterly finance reporting (USMA & GMA).
- Documentation and TMF management
- Upload and validate documentation in Teams and VCV; apply naming conventions and TMF artifact mapping; ensure “upload when due” adherence and audit readiness.
- For primary/hybrid studies, support site documentation (site lists, feasibility outputs, ICF versions, monitoring reports).
- Publication review and sign off coordination
- Coordinate author invitations, reviews, team feedback cycles and PSO-equivalent steps; track timelines and actions.
Requirements
- Bachelor’s degree in business, life sciences or a related field. Graduate-level degree in sciences or business preferred.
- Minimum 1 year of experience in the pharmaceutical or regulated medical products industry, preferably in evidence generation environment.
- Graduate-level degree in sciences or business.
- Familiarity with Oncology Medical and the pharmaceutical marketplace.
- Working knowledge of Evidence Generation Studies, TMF, supplier selection/oversight, PV/safety, and transparency.
- Experience coordinating publication review workflows and interfacing with authors and vendors
- Demonstrated operational excellence in a matrix environment, including coordination of contracting (CDA/MSA/RFP/SOW), vendor support (Scientist.com/CROs), and finance processes (POs, COUPA, cost centers).
- Proven capability with study systems and data stewardship (Veeva Clinical Vault, ABACUS, Airtable), documentation/TMF standards, and trial transparency.
- Strong proficiency preparing and tracking deliverables, maintaining audit-ready documentation, and presenting operational status to leadership.
What We Offer
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About Us
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