6 дней назад
Clinical Trial Manager (Oncology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Manager (Oncology) (Radiopharmaceutical Clinical Operations): Supporting the execution of early-stage oncology clinical trials, including site activation, enrollment, vendor oversight, study documentation, and clinical supplies with an accent on radiopharmaceutical studies, regulatory compliance, and cross-functional coordination. Focus on tracking trial risks and budgets, reviewing monitoring reports, maintaining Trial Master Files, and resolving operational issues across sites and vendors.
Location: Boston, Massachusetts, USA
Company
Clinical-stage biotechnology company developing radiopharmaceutical therapies for solid tumors through targeted radiation delivery, imaging studies, and therapeutic studies.
What you will do
- Track clinical trial timelines, budgets, operational metrics, risks, site activation, enrollment, and monitoring issues.
- Support CRO and vendor selection, country and site selection, feasibility questionnaires, and analysis of feasibility results.
- Manage day-to-day vendor relationships, including contracts, budgets, invoices, payments, and issue escalation.
- Provide operational input on protocols, informed consent forms, study manuals, reports, eCRFs, and regulatory documents.
- Maintain internal Trial Master File documentation and review CRO Trial Master File completeness and accuracy.
- Coordinate clinical supplies, investigator and study coordinator meetings, cross-functional issue resolution, and compliance with applicable regulations and SOPs.
Requirements
- Bachelor’s degree in Life Sciences or a related field; an advanced degree is preferred.
- 3–5 years of clinical operations experience in the pharmaceutical or biotechnology industry.
- Experience with early-stage oncology trials is required; radiopharmaceutical experience is preferred.
- Working knowledge of ICH/GCP regulations, FDA and EMA requirements, and clinical research SOPs.
- Strong organization, attention to detail, writing, communication, interpersonal, and problem-solving skills.
- Ability to work independently, coordinate across teams and vendors, and manage operational assignments proactively.
Nice to have
- Advanced degree in Life Sciences or a related field.
- Experience with radiopharmaceutical clinical trials.
Culture & Benefits
- Competitive salary, bonus, and equity.
- 20 vacation days, 5 sick days, paid holidays, and extended health benefits.
- Technology allowance and commuter reimbursement.
- Retirement savings plans with employer matching.
- Diverse and inclusive workplace with reasonable accommodations and equal employment opportunities.
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