2 дня назад
Clinical Trial Manager (Infectious Disease)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Manager (Infectious Disease) (Clinical Operations/ICH-GCP): Managing global infectious disease clinical trials from feasibility and study start-up through execution, data review, vendor coordination, and regulatory compliance with an accent on operational quality, timelines, and stakeholder collaboration. Focus on monitoring clinical data and reports, supporting clinical systems and UAT, coordinating CROs and investigator sites, and applying Generative AI-enabled technologies to improve trial execution and decision-making.
Location: Toronto, Canada; 70% in-office work model
Salary: $0.00–$0.00 base pay range; additional bonus, incentive compensation, or equity may be available.
Company
is a biotech company developing mRNA-based medicines and vaccines for infectious diseases, immuno-oncology, rare diseases, and cardiovascular diseases.
What you will do
- Manage day-to-day operational execution of assigned global clinical trials across study phases.
- Monitor timelines, risks, deliverables, clinical data, monitoring reports, and study performance metrics.
- Lead feasibility and study start-up activities and coordinate with Clinical Operations Leads, Clinical Trial Managers, CROs, vendors, and investigator sites.
- Develop investigator training materials, study manuals, and other site-facing documentation.
- Coordinate clinical trial sample preparation and transfer to external vendors.
- Support clinical trial systems, databases, UAT, and additional unblinded Clinical Trial Manager activities when required.
Requirements
- At least five years of clinical trial coordination experience in a clinical research or industry environment.
- Bachelor’s degree in a science-related discipline; an advanced degree is preferred.
- Experience supporting clinical trials in a global operating environment and a solid understanding of drug development.
- Strong project management, organizational, communication, and prioritization skills.
- Knowledge of FDA regulations, ICH-GCP guidelines, and applicable global regulatory requirements.
- At least two years of work authorization is required for this role.
Culture & Benefits
- 70/30 work model emphasizing in-office collaboration, innovation, teamwork, and mentorship.
- Healthcare and voluntary benefit programs, with offerings varying by employment nature and country.
- Fitness, mindfulness, mental health, and family-building support.
- Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
- Savings and investment programs plus location-specific perks.
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