The Role:

The Associate Clinical Trial Manager is involved in overall management, planning, implementation and execution of trials with oversight from the Clinical Operations Lead.

Here’s What You’ll Do:

• 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. This includes but is not limited to: 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 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

Here’s What You’ll Bring to the Table:

• 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

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• 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, which reflects the range permitted under California Labor Code requirements) . This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. 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.

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