обновлено 21 час назад
Clinical Trial Manager, Clinical Operations, Infectious Disease
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Manager, Clinical Operations, Infectious Disease (Clinical Trials/Generative AI): Managing the operational execution of global infectious disease clinical trials across study timelines, feasibility, clinical data, vendors, CROs, and investigator sites with an accent on quality, compliance, and operational speed. Focus on monitoring study performance, reviewing clinical data and monitoring reports, supporting clinical trial systems and UAT, and applying emerging Generative AI-enabled technologies to trial execution and decision making.
Location: Toronto, Canada
Company
is a biotechnology company developing an mRNA technology platform and medicines.
What you will do
- Manage the day-to-day operational execution of assigned global infectious disease clinical trials.
- Monitor study timelines, risks, deliverables, metrics, clinical data, and monitoring reports.
- Lead feasibility activities and support successful study start-up.
- Develop investigator training materials, study manuals, and other site-facing documentation.
- Coordinate clinical trial samples with external vendors and support clinical trial systems and database testing, including UAT.
- Collaborate with internal teams, CROs, vendors, investigator sites, and other stakeholders to maintain quality and compliance.
Requirements
- At least five years of clinical trial coordination experience in clinical research and industry settings.
- Advanced degree preferred, or a bachelor's degree in a science-related discipline.
- Experience supporting clinical trials in a global operating environment.
- Understanding of drug development, clinical trial execution, FDA regulations, and ICH-GCP guidelines.
- Strong project management, communication, organizational, and prioritization skills.
- At least two years of work authorization is required.
Culture & Benefits
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health support.
- Family-building benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs, plus location-specific benefits.
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