3 дня назад
Senior Clinical Trial Manager (Biotech)
150 000 - 175 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Manager (Biotech): Managing and overseeing clinical studies for an integrated cancer immunotherapy platform with an accent on study planning, CRO oversight, site activation, enrollment, and trial closeout. Focus on ensuring ICH/GCP compliance, managing investigational products and Trial Master Files, and coordinating complex cross-functional clinical operations.
Location: Remote within the United States; ideally based in Seattle, Washington, with onsite work at least 2 days per week. Approximately 20% travel may be required.
Salary: $150,000–$175,000 annual salary for the Senior Manager level.
Company
is a biotechnology company developing off-the-shelf cancer therapies through an integrated immunotherapy platform.
What you will do
- Manage the operational execution and oversight of clinical studies within quality, timeline, and budget requirements.
- Develop study timelines, deliverables, risk mitigation strategies, study plans, monitoring guidelines, and site materials.
- Lead CRO and vendor selection, performance management, study team meetings, and site monitoring activities.
- Track site start-up, activation, subject enrollment, data collection, and trial closeout.
- Manage site budgets and payments, investigator relationships, investigational product accountability, and product shipments.
- Oversee the Trial Master File and collaborate with Clinical Operations, Biometrics, Data Management, Regulatory Affairs, Pharmacovigilance, and Clinical Quality Assurance.
Requirements
- Bachelor’s degree or equivalent in Life Sciences.
- At least 8 years of clinical operations experience in the pharmaceutical industry, including 3+ years managing industry-sponsored clinical trials as a sponsor employee.
- Significant knowledge of GCP/ICH guidelines and the clinical development process.
- Experience independently planning and conducting clinical studies, managing CROs and vendors, and assessing performance.
- Experience leading, managing, or mentoring clinical operations staff and cross-functional teams.
- Ability to work onsite 2 days per week at the Seattle office or work remotely from within the United States.
Nice to have
- Experience supporting Phase 1 and Phase 2 clinical trials.
- Oncology experience.
Culture & Benefits
- Medical, dental, and vision insurance plans.
- 401(k) plan with a 100% match on the first 4% of employee deferral.
- Paid time off and commuter benefits.
- Cell phone stipend.
- Fast-paced, entrepreneurial environment focused on cancer treatment innovation.
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