Clinical Trial Manager

The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director, Clinical Operations and is accountable to the Clinical Operations Lead for assigned studies.This role maywork collaborativelyon one trial or across several trials to support clinical operations activities.

Roles and 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.

Qualification and Experience

• At least Six (6) years of trial coordination experience in a clinical research and industry environment.
• Holds an advanced degree or Bachelor’s in a science-based subject.
• Solid understanding of drug development.
• Project management and vendor oversight expertise.
• An understanding of current FDA and ICH GCP guidelines.
• Excellent verbal and written communication skills.
• Above average attention to detail.
• Ability to support multiple projects.