6 дней назад
Senior Clinical Trial Manager (Biotech)
180 000 - 220 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Manager (Biotech): Leading the execution and operational management of global Phase 2/3 clinical trials for the MAR002 acromegaly program with an accent on study delivery, CRO and vendor oversight, enrollment, budgets, and regulatory compliance. Focus on managing cross-functional study teams, mitigating operational risks, supporting clinical trial documentation and submissions, and maintaining inspection readiness under ICH-GCP requirements.
Location: South San Francisco, United States; on-site at least three days per week
Salary: $180,000–$220,000 per year
Company
is a clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine diseases, including MAR001 for severe hypertriglyceridemia and MAR002 for acromegaly.
What you will do
- Lead the day-to-day execution, oversight, and delivery of clinical studies for the MAR002 program.
- Manage the Study Management Team and coordinate cross-functional study execution across start-up, enrollment, maintenance, and close-out.
- Oversee CROs and vendors, including vendor selection, contracts, work orders, performance indicators, and operational governance.
- Identify study risks, implement mitigation plans, and support site engagement and subject recruitment strategies.
- Contribute to trial design, study-level documentation, regulatory submissions, budgets, and operating plans.
- Lead or support inspection readiness, clinical SOP development, and process improvement initiatives.
Requirements
- BA/BS or higher degree in a relevant scientific discipline.
- 6–9 years of clinical research or clinical operations experience in the pharmaceutical industry.
- Global Phase 2–3 clinical trial experience.
- Experience leading cross-functional study execution teams and managing CROs and vendors.
- Strong communication, presentation, problem-solving, conflict management, organizational, and project execution skills.
- In-depth knowledge of clinical research regulations and guidelines, including ICH-GCP, with the ability to work across multiple time zones.
Nice to have
- Biotechnology or small-pharma experience.
- Experience mentoring junior team members.
Culture & Benefits
- Hands-on, collaborative environment where employees work directly across levels and functions.
- Dynamic clinical-stage biotechnology setting with opportunities to support multiple development programs.
- Occasional travel may be required to meet business objectives.
- Role involves desk- and computer-based work, with occasional handling of objects weighing up to 20 pounds.
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