9 часов назад
Senior Clinical Trial Manager, Clinical Operations (Oncology)
152 000 - 190 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Manager, Clinical Operations (Oncology) (Early-Phase Oncology Trials): Leading end-to-end operational execution of complex oncology studies from start-up through close-out with an accent on CRO oversight, enrollment strategy, regulatory compliance, and inspection readiness. Focus on managing global multi-site trials, mitigating operational risks, coordinating cross-functional teams, and maintaining timeline, budget, and data quality performance.
Location: Remote in the United States or onsite in San Diego, California; up to 10% travel required.
Salary: $152,000–$190,000 per year
Company
is a clinical-stage life-science and technology company developing medicines through an AI-driven drug discovery and development platform.
What you will do
- Lead complex early-phase oncology clinical trials from start-up through close-out, ensuring on-time, on-budget, compliant delivery.
- Coordinate cross-functional study teams across Clinical Development, Regulatory, Biometrics, Data Management, Medical, and external partners.
- Develop enrollment, site management, monitoring, training, and study execution strategies.
- Oversee CRO and vendor performance, including KPIs, monitoring quality, document review, approval, and vendor selection support.
- Manage protocols, informed consent forms, project plans, budgets, study materials, and operational tools.
- Identify and mitigate operational risks, support data review and query resolution, and mentor junior clinical operations staff.
Requirements
- Bachelor’s degree in life sciences or a related field and 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, or CRO environments.
- Experience managing global, multi-site clinical trials from start-up through close-out and overseeing CRO partners.
- Required oncology clinical trial experience; solid tumor and early-phase Phase I/Ib or II experience preferred.
- In-depth knowledge of ICH-GCP, FDA/EMA regulations, global regulatory requirements, quality standards, and inspection readiness.
- Proficiency with CTMS, eTMF, IRT, EDC, and safety database systems.
- Ability to work in a collaborative, fast-paced, growth-stage biotech environment with evolving priorities and high accountability.
Nice to have
- Experience with solid tumor studies and early-phase Phase I/Ib or II trials.
- Experience mentoring clinical operations staff or managing through dotted-line reporting relationships.
Culture & Benefits
- Collaborative, inclusive environment bringing together AI experts and experienced drug developers.
- Company-paid healthcare and flexible spending accounts.
- 401(k) matching and voluntary life insurance.
- Uncapped vacation.
- San Diego facility with an onsite gym and dining.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
9 часов назад
Senior Clinical Trial Manager (Oncology)
143 000 - 173 250$
9 часов назад
Clinical Trial Manager, Oncology, Asia
130 000 - 157 500$
9 часов назад
Associate Director, Clinical Study Management, EMEA/LATAM (Oncology)
183 000 - 220 500$
3 дня назад
Director of Clinical Affairs (Medical Devices)
200 000 - 250 000$
9 часов назад
Senior Clinical Quality Operations Manager
157 000 - 189 000$
4 дня назад