Global Clinical Trial Manager

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

Benefits offered by this job

Competitive healthcare

Paid time off

Global benefits

Job summary

Moderna Therapeutics in Cambridge, MA seeks a Clinical Trial Manager to oversee assigned trials, ensuring quality, compliance and timely delivery. You will manage CROs/vendors, collaborate with Clinical Operations, draft site materials, monitor data, and maintain trial metrics across global regions.

The role requires 5+ years of trial coordination experience, strong FDA/ICH GCP knowledge, and exceptional communication and project management skills.

Qualifications

• At least 5 years of trial coordination experience in a clinical research/industry setting.
• Advanced degree preferred or Bachelor’s in a science-based subject.
• Relevant experience in global settings.
• Solid understanding of drug development.
• Good project management skills.
• Good understanding of FDA and ICH GCP guidelines for 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 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

Vendor management

Clinical operations

GCP knowledge

Communication skills

Education

Advanced degree preferred

Bachelor’s in science

Job description

Moderna Therapeutics in Cambridge, MA seeks a Clinical Trial Manager to oversee assigned trials, ensuring quality, compliance and timely delivery. You will manage CROs/vendors, collaborate with Clinical Operations, draft site materials, monitor data, and maintain trial metrics across global regions.

The role requires 5+ years of trial coordination experience, strong FDA/ICH GCP knowledge, and exceptional communication and project management skills.