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.

• 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
• 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.