RWE Study Operations Lead

Moderna; Cambridge (MA); On-site; USD 109,000 - 175,000; Full time

Job summary

Moderna seeks a Manager, RWE Study Operations to provide operational leadership for multiple Real-World Evidence studies, coordinating cross-functional teams with research partners, vendors, and sites. This role requires strong project management, vendor oversight, organizational, and problem-solving skills in a fast-paced environment.

This position will report to the Director of RWE Study Operations and will work across several studies, including PASS, PMS, registry, epidemiological, and other

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 4+ years in clinical research or industry with project management.
• Experience managing CROs, vendors, contracts, and budgets.
• Strong communication and problem-solving skills.
• Familiarity with FDA/ICH GCP and regulatory guidance.

Responsibilities

• Lead day-to-day operational management of multiple RWE studies.
• Coordinate cross-functional study teams and provide backup PM support.
• Lead vendor outsourcing activities with SL, Legal, and Procurement.
• Oversee vendor performance, quality, timeline, budget, and deliverables.
• Develop and maintain study management documents.
• Communicate study status, timelines, and issues to stakeholders.
• Create and maintain study timelines with SL and stakeholders.
• Manage Trial Master File where required.
• Review protocols and regulatory documents for operational input.
• Oversee data transfer activities and data privacy compliance.
• Lead study closure, including regulatory, financial, and documentation.
• Identify opportunities to improve processes and RWE operating models.

Skills

Project management

Vendor management

Cross-functional collaboration

Problem solving

Communication

AI tools familiarity

Education

Bachelor’s degree required

Advanced degree preferred

Tools

CRO management tools

Contract budgeting tools

Job description

Moderna seeks a Manager, RWE Study Operations to provide operational leadership for multiple Real-World Evidence studies, coordinating cross-functional teams with research partners, vendors, and sites. This role requires strong project management, vendor oversight, organizational, and problem-solving skills in a fast-paced environment.

This position will report to the Director of RWE Study Operations and will work across several studies, including PASS, PMS, registry, epidemiological, and other