Research Collaboration Study Manager
Pfizer
- Location
- Poland - Warsaw
- Work model
- On-Site
- Level
- Mid
- H-1B history
- 9 approvals (FY2023)
- Posted
- 9h ago
About this role
Job Title: Research Collaboration Study Manager Role Overview Research Collaborations (RCs) are research studies in which Pfizer partners with external collaborators to develop, conduct, and execute research that supports Pfizer business, medical, or regulatory goals. The Research Collaboration Study Manager (RC SM) provides end-to-end operational study management for Pfizer-supported RCs, ensuring studies are initiated, maintained, tracked, and closed in alignment with applicable processes, timelines, contractual obligations, and compliance requirements. The RC SM is responsible for day-to-day operational coordination and oversight of assigned RC studies within assigned therapeutic area(s). The RC SM supports one or more assets and/or Business/Research Units that engage with external collaborators, including but not limited to principal investigators, academic research organizations, cooperative groups or networks, relevant government agencies, alliance partners, and vendors supporting RC activities. Primary Duties: The Research Collaboration Study Manager (RC SM): Is responsible for all operational study management activities for assigned studies. Leads and manages the operational execution of assigned Research Collaboration studies from startup through closure to ensure timely delivery of study deliverables. Serves as the primary operational point of contact with the collaborator and coordinates internally with Pfizer stakeholders for scientific, medical, legal, financial, and operational inputs as needed. Facilitates operational coordination between Pfizer and external collaborators during development and review of key study documents, such as the protocol and informed consent document, as applicable. Coordinates with subject matter experts from study concept development through study completion. Ensures required study information, documentation, and system records are maintained in accordance with applicable SOPs, processes, and system requirements. Supports development and operational implementation of study contractual requirements, including deliverables, milestones, payment terms, and amendments as needed. Organizational Relationships: Reports to the Research Collaboration Lead. Partners with the RC-Project Managers assigned to each therapeutic area for project assignments as well as escalating concerns and issue resolution.
Responsibilities
Partners with the Medical/Asset Team, Finance Lead, and Partner Line representatives to support study-level budget development, tracking, forecasting inputs, and reconciliation activities. Ensures study team understands key milestones and interdependencies. Develops and maintains operational timelines, delivery milestones, action logs, and risk mitigation plans in collaboration with the study team. Monitors RC progress and milestones to ensure on track with projected timelines and to escalate if off track. Supports collaborators with required system entries, process expectations, document submission requirements, and operational follow-up. Initiates required investigator eligibility checks and tracks completion of associated documentation. Reviews budget, obtains fair market value assessment and facilitates final budget discussions with study team and collaborator. Facilitates discussions on resource availability at Pfizer to support the collaboration (ie funding, drug, assay etc.) Facilitates due diligence meetings and ensures ratings and documentation are complete. Prepares draft agreements, coordinates operational review and negotiation inputs, partners with Legal, and facilitates final agreement execution and amendments as necessary. Tracks operational study elements, including deliverables, milestones, action items, payments, documentation status, and issue resolution. Leads study team meetings, including agenda preparation, meeting minutes, action tracking, decision documentation, and follow-up. Manages collection, delivery, and documentation of all contractually required