4 дня назад
Associate Clinical Trial Manager (Infectious Disease)
89 900 - 143 800$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Clinical Trial Manager (Infectious Disease) (Clinical Operations): Managing and coordinating infectious disease clinical trials across study activities, regions, vendors, sites, and regulatory submissions with an accent on trial execution, CRO oversight, clinical systems, and ICH/GCP compliance. Focus on developing study documents, supporting site and budget management, coordinating clinical data and investigational product delivery, and maintaining trial quality metrics.
Location: Remote - US; only U.S. persons are eligible due to U.S. export control requirements.
Salary: $89,900–$143,800 per year; California range: $111,600–$128,400.
Company
develops mRNA technology and medicines, with a focus on infectious disease and clinical research.
What you will do
- Manage assigned clinical trial responsibilities across study phases, regions, countries, vendors, and clinical activities.
- Support clinical development strategy, study plans, timelines, budgets, contracts, and CRO oversight.
- Contribute to protocols, consent forms, clinical study plans, CRFs, data reviews, and clinical system testing.
- Assist with site feasibility and selection, investigational product delivery, monitoring oversight, and clinical quality metrics.
- Support IRB/IEC and regulatory submissions, TMF document quality checks, trial reporting, and CTA mentoring when required.
- Ensure assigned trials are conducted according to and ICH/GCP standards.
Requirements
- Must be a U.S. person eligible to access export-controlled information under U.S. law.
- At least 2 years of trial coordination experience in a clinical research and industry environment, with up to 5 years of relevant experience.
- Bachelor’s degree in a science-based subject; an advanced degree is preferred.
- Relevant experience in a global clinical research setting and a solid understanding of drug development.
- Good project management, organizational, communication, and attention-to-detail skills.
- Good understanding of FDA and ICH GCP guidelines.
Culture & Benefits
- Remote work within the United States with location-specific perks.
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health support.
- Family planning, fertility, adoption, and surrogacy benefits.
- Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs, with potential bonus, incentive compensation, or equity eligibility.
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