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.