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[Hiring] Associate Clinical Trial Manager @Moderna
Role Description
The Associate Clinical Trial Manager is involved in overall management, planning, implementation and execution of trials with oversight from the Clinical Operations Lead.
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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, including:
- 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
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Collaborate and support 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
- 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 team with 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
Qualifications
- 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
- Advanced degree preferred or 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
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
The salary range for this role is $89,900.00 - $143,800.00 (for positions that may be performed in California, the expected salary range is $111,600.00 - $128,400.00). The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
