RWE Study Operations Lead

Moderna Therapeutics; Cambridge (MA); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare

Paid time off

Bonus potential

Job summary

Moderna leads in mRNA therapeutics and real-world evidence studies. The Manager, RWE Study Operations provides operational leadership for multiple RWE studies, coordinating cross-functional teams to ensure successful study execution and timely delivery.

This role requires strong project management, vendor oversight, and problem-solving skills in a fast-paced environment, with collaboration across research partners, vendors, and sites across various study types.

Qualifications

• 4+ years of experience in a clinical research environment, including 2+ years of independent study or project management at a sponsor company preferred.
• Experience in observational research, trial or program management across lifecycle.
• Understanding of clinical drug development and Real-World Evidence across the product lifecycle.

Responsibilities

• Oversee day-to-day operational PM and study deliverables.
• Coordinate cross-functional study teams and backup PM support.
• Lead outsourcing activities with SL, Legal and Procurement as needed.
• Ensure adherence to GxP and regulatory guidelines throughout studies.

Skills

Project management

Vendor management

Cross-functional collaboration

Communication

Education

Bachelor’s degree

Advanced degree

Tools

ChatGPT

Microsoft Copilot

Job description

Moderna leads in mRNA therapeutics and real-world evidence studies. The Manager, RWE Study Operations provides operational leadership for multiple RWE studies, coordinating cross-functional teams to ensure successful study execution and timely delivery.

This role requires strong project management, vendor oversight, and problem-solving skills in a fast-paced environment, with collaboration across research partners, vendors, and sites across various study types.