Associate Clinical Trial Manager, Clinical Operations, Infectious Disease

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee, organize, implement, and carry out clinical trials with guidance from the Clinical Operations Lead.

• Manage designated study tasks and deliverables throughout all phases of the trial.

• Handle smaller studies, regions, or countries within larger trials, as well as manage vendors or activities across multiple trials.

• Act as a deputy for the Clinical Operations Lead when necessary.

• Contribute to the creation of study documents, which include protocols, consent forms, and clinical study plans.

• Assist in developing clinical strategies, budgets, and plans; oversee study-level timelines.

• Supervise activities of CROs and subcontracted vendors.

• Engage in the clinical review of CRFs, CRF completion guidelines, and data analysis.

• Take part in clinical system configuration and testing, involving EDC and IRT.

• Aid in the identification, selection, and feasibility assessment of clinical sites.

• Monitor and manage clinical site budgets and contracts effectively.

• Coordinate the delivery of investigational products to sites in collaboration with the Clinical Supply team.

• Provide support for monitoring oversight, clinical trial insurance, deviation processes, and clinical quality metrics.

• Maintain trial metrics and generate regular reports.

• Perform Clinical Trial Associate duties as needed, including mentoring new CTAs.

• Assist with submissions to IRB/IEC and regulatory bodies.

• Organize document uploads and quality-control checks with the TMF team.

• Ensure compliance of trials with Moderna and ICH/GCP standards.

⛳️ Requirements

• Minimum of 2 years of experience in trial coordination within a clinical research and industry setting, with up to 5 years of experience in the clinical research field.

• Advanced degree preferred; a Bachelor’s degree in a science-related discipline is required.

• Relevant experience in a global context.

• Strong understanding of drug development processes.

• Effective project management skills.

• Comprehensive knowledge of FDA and ICH GCP guidelines.

• Exceptional verbal and written communication abilities.

• Strong organizational skills and meticulous attention to detail.

• Must qualify as a U.S. person under U.S. export control regulations: citizen, permanent resident, asylee, or refugee.

• Moderna is unable to sponsor applications for an export control license for non-U.S. persons.

🏝️ Benefits

• Competitive healthcare options, along with various voluntary benefit programs.

• Access to fitness, mindfulness, and mental health resources.

• Family planning benefits, including support for fertility, adoption, and surrogacy.

• Generous paid time off encompassing vacation, volunteer days, sabbaticals, global recharge days, and a discretionary year-end shutdown.

• Savings and investment opportunities to assist in future planning.

• Location-specific perks and additional benefits.

• Potential for an annual discretionary bonus, other incentive compensation, or equity awards, subject to company eligibility criteria and individual performance.