Associate Clinical Trial Manager, Clinical Operations, Infectious Disease

🔥 10 minutes ago

🇺🇸 United States – Remote

💵 $89.9k - $143.8k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Moderna

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2010

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Moderna is a biotechnology company focused on exploring the potential of messenger RNA (mRNA) science to develop a new generation of medicines. With 45 products in the pipeline and 36 ongoing clinical trials, Moderna aims to revolutionize treatment possibilities by enabling the immune system to combat diseases more effectively. Their platform allows for the rapid design, research, and testing of multiple mRNAs, facilitating faster delivery of medicines to patients.

📋 Description

• Manage, plan, implement, and execute clinical trials under oversight from the Clinical Operations Lead • Manage assigned study responsibilities and deliverables across all trial phases • Manage small studies, regions or countries within larger trials, and vendors or activities across multiple trials • Deputize for the Clinical Operations Lead as needed • Contribute to study documents, including protocols, consent forms, and clinical study plans • Assist with clinical development strategy, budgets, and plans; manage study-level timelines • Oversee CRO and subcontracted vendor activities • Participate in clinical review of CRFs, CRF completion guidelines, and data review • Participate in clinical system build and testing, including EDC and IRT • Assist with clinical site identification, selection, and feasibility • Monitor and manage clinical site budgets and contracts • Coordinate investigational product delivery to sites with the Clinical Supply team • Support monitoring oversight, clinical trial insurance, deviation processes, and clinical quality metrics • Maintain trial metrics and provide routine reporting • Perform Clinical Trial Associate tasks when required, including mentoring new CTAs • Support submissions to IRB/IEC and regulatory authorities • Coordinate document upload and quality-control checks with the TMF team • Ensure trials comply with Moderna and ICH/GCP standards

🎯 Requirements

• 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 • Excellent verbal and written communication skills • Good organizational skills and attention to detail • Must qualify as a U.S. person under U.S. export control laws: citizen, permanent resident, asylee, or refugee • Moderna is unable to sponsor non-U.S. persons to apply for an export control license

🏖️ Benefits

• Competitive healthcare, plus voluntary benefit programs • 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 • Annual discretionary bonus, other incentive compensation, or equity award may be available, subject to company plan eligibility criteria and individual performance