Manager, RWE Study Operations

What You'll Do

• Perform day-to-day operational project management and oversight of assigned RWE studies to ensure deliverables are met for all assigned studies.
• 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.
• 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 workstreams 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 specifications (DTS), ensuring data quality, integrity, and compliance with study protocol and data privacy requirements.
• Lead study closure activities, ensuring completion of regulatory, financial, and documentation requirements in alignment with study closeout checklists.

What You'll Bring to the Table

• 4+ years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent study or project management at a sponsor-company preferred
• Bachelor's degree required; Advanced degree preferred
• Relevant experience in observational research, experience in trial management or program management across more than one phase of development, and across entire lifecycle of a study preferred
• Understanding of clinical drug development and the role of Real-World Evidence across the product lifecycle.
• Strong project management, planning, and organizational skills.
• Familiarity with AI-enabled productivity tools (e.g., ChatGPT, Microsoft Copilot) and the ability to leverage digital technologies to improve operational efficiency.
• Demonstrated experience managing CROs, vendors/research partners, contracts, budgets, and operational performance.
• Critical thinker and problem solver with good organizational skills
• Ability to work with urgency and prioritize across multiple studies
• Working knowledge of FDA and ICH GCP, GPP, and applicable regulatory guidance.
• Excellent verbal and written communication skills