Associate Clinical Trial Manager, Clinical Operations, Infectious Disease

Moderna

5d • $89,900 - $143,800 • Remote

About The Position

The Associate Clinical Trial Manager is involved in overall management, planning, implementation and execution of trials with oversight from the Clinical Operations Lead. This role is responsible for the day-to-day management of assigned study responsibilities to ensure deliverables are met in all phases of trial. This includes management of small studies, managing regions or countries within a larger clinical trial, or managing vendors/activities across multiple trials. The Associate Clinical Trial Manager may also deputize for the Clinical Operations Lead as needed.

Requirements

• At least 2 years of trial coordination experience in a clinical research and industry environment with up to 5 years experience in a clinical research and industry environment.
• 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.
• Must qualify as a U.S. person (citizen, permanent resident, asylee, or refugee) due to export control laws.

Nice To Haves

• Advanced degree preferred or Bachelor’s in a science-based subject.

Responsibilities

• Day to day management of assigned study responsibilities as delegated by the Clin Ops Lead to ensure deliverables are met in all phases of trial.
• Management of small studies at various points in the trial lifecycle, managing regions or countries within a larger clinical trial, managing vendors or activities across multiple trials.
• Deputize for Clin Ops Lead, as needed.
• Contribute to development of study documents (protocol, consent forms, clinical study plans, etc.), including drafting updates and managing reviews.
• Assist team with clinical development strategy, budget, and plan and manage study-level timelines with oversight from Clin Ops Lead.
• Management and oversight of assigned CRO activities and/or subcontracted vendors activities, under oversight from Clin Ops Lead.
• Participate in clinical review of CRFs, CRF completion guidelines, and data review.
• Participate in clinical system build and test efforts (EDC, IRT, etc.).
• Assist in identification and selection of clinical sites, including feasibility process.
• Assist in monitoring and managing budgets and contracts for clinical sites.
• Provide input and coordinate delivery of IP to sites in collaboration with Clinical Supply team.
• Collaborates and supports Clin Ops Lead and/or Program Clin Ops Lead to perform key tasks within the clinical trial process such as monitoring oversight, managing clinical trial insurance, deviation processes and clinical quality metrics.
• Support maintenance of trial metrics, including routine reporting as assigned.
• May perform some Clinical Trial Associate tasks if required, including mentoring of new CTAs.
• Support submissions to IRB/IEC and regulatory authorities.
• Liaise and coordinate document upload and QC checks with TMF team.
• Ensure assigned trial or part of trial is conducted in accordance with Moderna and ICH/GCP standards.

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.

What This Job Offers

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