3 дня назад
Clinical Trial Manager (Contract)
72 - 82$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Manager (Contract) (Biotechnology): Managing day-to-day operations of Phase 1–3 clinical trials, including startup, conduct, closeout, CRO oversight, documentation, budgets, and site activities with an accent on retina trials, GCP compliance, and cross-functional execution. Focus on coordinating complex study deliverables, maintaining audit-ready trial documentation, managing risks and protocol deviations, and controlling timelines, quality, and costs.
Location: Remote within the United States; company location in Emeryville, California. Travel to clinical sites, conferences, and industry meetings as needed; approximately 5% travel.
Salary: $72.00–$82.00 per hour.
Company
is a biotechnology company developing targeted AAV gene therapies for rare and large-market diseases through its Therapeutic Vector Evolution platform.
What you will do
- Manage day-to-day operations for one or more Phase 1–3 clinical trials from startup through closeout.
- Oversee CROs, service providers, consultants, monitors, and investigational sites while leading cross-functional study execution.
- Track study milestones, timelines, budgets, quality metrics, protocol deviations, clinical supplies, and financial performance.
- Prepare and review protocols, informed consents, investigator brochures, monitoring plans, case report forms, statistical analysis plans, and clinical study reports.
- Maintain the Trial Master File and audit-ready clinical documentation, and coordinate resolution of audit findings and site issues.
- Support site selection, feasibility, training, contracting, monitoring visits, data review, and process improvement initiatives.
Requirements
- B.A. or B.S. degree in Science.
- 6+ years of clinical research experience in biotechnology or a similar industry.
- At least 2 years of direct experience supporting retina clinical trials.
- Knowledge of GCP, ICH guidelines, regulatory requirements, clinical trial methodology, and clinical study management.
- Experience with trial planning, site monitoring, risk mitigation, site selection, budgets, clinical supplies, and protocol execution.
- Strong communication, organization, negotiation, conflict resolution, prioritization, problem-solving, collaboration, and Microsoft Office skills; working knowledge of MS Project.
Nice to have
- Global APAC clinical trial experience.
- Experience developing therapeutic area knowledge through training and industry conferences.
Culture & Benefits
- Work in a collaborative, results-driven biotechnology environment focused on gene therapy innovation.
- Opportunities for career development and challenging clinical operations work.
- Company values include patient focus, calculated risk-taking, innovation, collaboration, and disciplined execution.
- Equal employment opportunity is provided in accordance with applicable laws.
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