Clinical Trial Manager, Clinical Operations, Infectious Disease

ModernaTX • Bethesda, MA

27d • Onsite

About The Position

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 may work collaboratively on one trial or across several trials to support clinical operations activities.

Requirements

• At least 5 five years of trial coordination experience in a clinical research and industry environment
• 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

Nice To Haves

• Advanced degree preferred

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

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras
• Annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level