Manager, RWE Study Operations

The Manager, RWE Study Operations provides operational leadership for multiple Real-World Evidence (RWE) studies and coordinates cross-functional teams to ensure successful study execution and delivery. This role requires strong project management, vendor oversight, organizational, and problem-solving skills in a fast-paced environment. This position will work with a variety of internal and external team members including research partners, vendors and sites. The position may report to the Director of RWE Study Operations (or above).

This role will work across multiple studies to support study management operations activities. The types of studies to be managed in the RWE Study Operations team include but are not limited to Post Authorization Safety Studies (PASS), Post Market Surveillance (PMS) safety studies, Registry Studies, Epidemiological studies, Real World Evidence (RWE) Effectiveness studies, other RWE studies, Integrated Evidence studies and collaborative studies.

• Perform day-to-day operational project management and oversight of assigned RWE studies to ensure deliverables are met for all assigned studies.
• Role may include ~6-10 studies across different programs depending on study complexity.
• Coordinate and lead the cross-functional study team as well as provide backup study management support as needed to other team members.
• Initiate and lead the vendor outsourcing/contracting activities, if applicable, in collaboration with the study Scientific Lead, Outsourcing, Legal, and Procurement team members and other team members as applicable.
• Oversee vendor or research partner performance throughout the study lifecycle to ensure quality, timeline, budget, and contractual deliverables are met.
• Develop and maintain study management documentation, including the Project Management Plan template Communicate study status, timelines, budget, and issues to key stakeholders to ensure timely decision making by management.
• Develop, maintain, and communicate study timelines in collaboration with the Scientific Lead (SL) and key stakeholders.
• Create, oversee, and/or organize internal team reviews of study documentation and reports.
• Implement and ensure management of the Trial Master File, if required.
• Review and provide operational input into protocols, study plans, regulatory documents, publications, study reports, and other study documentation.
• Oversee biomarker sample tracking and chain of custody, when applicable, to support timely laboratory analysis and study deliverables.
• Complete and maintain study metrics in trackers and other internal tools including MOST, study team lists, action decision logs, etc.
• Ensure studies are conducted in accordance with Moderna SOPs and policies and appropriate GxP requirements, Good Pharmacoepidemiology Practices (GPP), and applicable regulatory guidelines.
• Support user acceptance testing (UAT) of study systems and databases, as applicable.
• Manage study contracts including review/approval and tracking of invoices, budget management, forecasting and accrual activities.
• Participate in work streams related to departmental and operating model improvement initiatives.
• Develop and maintain strong, collaborative relationships with key stakeholders within and external to Moderna.
• Identify opportunities to improve operational processes, study execution, and RWE operating models.
• Identify, document, and manage study-level risks, including maintaining a risk log and coordinating periodic risk reviews with the Study Team, as applicable.
• Collaborate with Clinical Trial Transparency & Disclosure (CTTD) and Regulatory teams to support study registration, disclosure, and regulatory submissions, as applicable.
• Oversee data transfer activities and…