5 дней назад
Clinical Trial Manager (CTM) (Biopharmaceutical)
157 700 - 168 200$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Trial Manager (CTM) (Biopharmaceutical): Managing assigned clinical trials from protocol development through close-out with an accent on CRO and vendor oversight, clinical site relationships, enrollment, budgets, and regulatory compliance. Focus on leading study teams, coordinating trial documentation and data deliverables, preparing for audits, and solving recruitment and operational risks.
Location: Onsite in Brisbane, California, United States; ability to travel as required for the program, approximately 25%
Salary: $157,700–$168,200 annually for roles based in the San Francisco Bay Area
Company
is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases through an AI-integrated discovery engine.
What you will do
- Own the operational management of assigned clinical trials from protocol development through close-out.
- Lead study teams, CROs, vendors, clinical monitors, investigators, and study coordinators.
- Manage trial timelines, budgets, forecasting, accruals, vendor payments, enrollment, and recruitment challenges.
- Coordinate protocols, informed consents, CRFs, monitoring plans, study reports, and data deliverables with Data Management.
- Track trial progress, communicate status, identify risks, and recommend solutions.
- Prepare for and support regulatory agency audits and inspections while representing Clinical Operations in project meetings.
Requirements
- Bachelor’s degree in biological sciences and 5+ years of relevant industry experience.
- Independent clinical trial management experience from study start-up through close-out.
- Working knowledge of FDA, EMA, ICH, and GCP regulations and guidelines.
- Experience leading CRO and vendor relationships and directing study teams.
- Strong analytical, problem-solving, communication, organization, and prioritization skills.
- Ability to work onsite in Brisbane, California, and travel approximately 25% as required.
Culture & Benefits
- Collaborative, strongly team-oriented environment.
- Solutions- and results-oriented approach.
- Hands-on and resourceful working style.
- Openness to diverse points of view.
- Fast-paced small-company environment with autonomy and experienced team support.
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