Global Clinical Trial Lead

RXinsider LTD.; Cambridge (MA); On-site; USD 109,000 - 175,000; Full time

Job summary

Moderna is seeking a Clinical Trial Manager to provide oversight for assigned trials, ensuring quality, compliance, and timely deliverables. The role emphasizes strong vendor management and collaboration with the Clinical Operations team across global studies.

You will work with the Clinical Operations Lead to execute studies, draft site materials, monitor data, and maintain trial metrics while ensuring adherence to FDA/ICH GCP standards. A 70/30 in-office work model supports collaboration.

Qualifications

• At least 5 years of trial coordination experience in a clinical research and industry environment.
• Advanced degree preferred or Bachelor’s in a science-based subject.
• Relevant experience in global setting.
• Solid understanding of drug development.
• Good project management skills.
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
• Excellent verbal and written communication skills.
• Good organizational skills and attention to detail.

Responsibilities

• Day to day management of assigned clinical trial(s) to ensure deliverables are met in all phases of trial.
• Communication to internal team members on deliverables and ensuring timelines are met.
• Manage trial feasibility process.
• Work closely with study Clinical Operations Lead and/or assigned Clinical Trial Manager(s) to execute clinical studies.
• Drafting site materials including training, manuals and support documentation.
• Monitoring of clinical data to ensure timely entry and readiness for data review meetings.
• Periodic review of clinical data.
• Review of clinical monitoring reports to ensure timely completion and identification of issues.
• Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables.
• Maintain trial metrics.
• Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials.
• Support testing clinical trial systems/databases (i.e. UAT).
• May support additional clinical trial(s) in an unblinded Clinical Trial Manager capacity.
• Develop and maintain strong, collaborative relationships with key stakeholders within Moderna.

Skills

Trial coordination

Global experience

Project management

FDA/ICH GCP knowledge

Communication skills

Organizational skills

Education

Advanced degree or Bachelor's in a science-based subject

Job description

Moderna is seeking a Clinical Trial Manager to provide oversight for assigned trials, ensuring quality, compliance, and timely deliverables. The role emphasizes strong vendor management and collaboration with the Clinical Operations team across global studies.

You will work with the Clinical Operations Lead to execute studies, draft site materials, monitor data, and maintain trial metrics while ensuring adherence to FDA/ICH GCP standards. A 70/30 in-office work model supports collaboration.