8 часов назад
Clinical Trial Manager, Oncology, Asia
130 000 - 157 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Manager, Oncology, Asia (Clinical Operations): Managing international in-sourced oncology clinical trials from start-up through closeout with an accent on study oversight, regulatory compliance, site execution, and high-quality data delivery. Focus on coordinating cross-functional teams and vendors, identifying study risks and deviations, maintaining trial documentation, and ensuring adherence to ICH-GCP and FDA requirements.
Location: Hybrid onsite in Millbrae, CA or Jersey City, NJ, at least 3 days per week
Salary: $130,000–$157,500 per year, plus bonus and equity compensation
Company
Therapeutics is a biopharmaceutical company developing novel treatments through technologies combining chemistry, engineering, computation, and biology.
What you will do
- Manage international in-sourced oncology clinical trials from start-up through closeout, delivering quality data on time and within budget.
- Develop and execute operational plans, including site selection, feasibility assessments, study documentation, initiation, training, and monitoring.
- Coordinate with clinical study management, data management, clinical science, regulatory, investigators, and other cross-functional stakeholders.
- Monitor study progress, identify risks, issues, and deviations, and implement corrective actions.
- Oversee CROs, central laboratories, imaging providers, investigators, coordinators, and study site personnel as required.
- Lead the creation and maintenance of the study master file, site files, Sponsor Trial Master File, protocols, informed consent forms, CRFs, and SOPs.
Requirements
- PhD with 3 years, Master’s degree with 6 years, or Bachelor’s degree with 8 years of relevant experience.
- Clinical Operations experience and demonstrated management of clinical trials from start-up to closeout; oncology trial experience is preferred.
- In-depth knowledge of oncology clinical trial regulations and best practices, including ICH-GCP and FDA requirements.
- Strong project management, prioritization, resource allocation, budgeting, analytical, and problem-solving skills.
- Proficiency with Veeva clinical trial management systems and familiarity with oncology treatment modalities, disease progression, and medical terminology.
- Proficiency in Mandarin, Cantonese, Japanese, or Korean and strong English reading, writing, and speaking skills are required.
Culture & Benefits
- Collaborative, agile, detail-oriented environment focused on operational excellence and advancing patient care.
- 401(k) plan with company matching.
- Medical, dental, vision, mental health, and wellness benefits.
- Generous paid time off, holiday policies, and weeklong summer and winter shutdowns.
- Enhanced parental leave, life and AD&D insurance, and a subsidized onsite lunch program.
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