4 дня назад
Clinical Trial Manager (Biotech)
131 000 - 181 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Trial Manager (Biotech): Planning, executing, overseeing, and delivering global clinical trials for allogeneic gamma delta T cell therapies with an accent on GCP/ICH compliance, site management, CRO oversight, and study milestones. Focus on leading study execution meetings, managing clinical trial documentation and metrics, performing co-monitoring visits, and addressing operational risks across cross-functional teams.
Location: Redwood City, California, United States; onsite at least three days per week, with Tuesday–Thursday mandatory
Salary: $131,000–$181,000 USD per year
Company
is a clinical-stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer.
What you will do
- Plan, execute, oversee, and deliver assigned global clinical trials in compliance with GCP, ICH guidelines, SOPs, timelines, and budgets.
- Lead site and study management activities, including informed consent forms, site activation, monitoring reports, and study plan development.
- Lead and present at Study Execution Team meetings and collaborate with cross-functional teams to resolve routine study issues.
- Oversee CROs and vendors, track milestones, identify issues for escalation, and implement risk mitigation plans.
- Perform co-monitoring visits during site qualification, initiation, routine monitoring, and close-out.
- Maintain clinical trial master files, reports, listings, trackers, and site enrollment metrics.
Requirements
- BS or higher degree in science, nursing, or an equivalent discipline.
- At least four years of clinical research experience in biotechnology, pharmaceutical, or CRO settings.
- Experience working with CROs and vendors and managing projects, contracts, vendors, and clinical research staff.
- Strong working knowledge of FDA requirements, ICH guidelines, and GCPs governing clinical trials.
- Experience with electronic data capture systems and Institutional Review Board preparations and submissions.
- Ability to work onsite in Redwood City at least three days per week, with Tuesday–Thursday mandatory.
Nice to have
- Knowledge of molecular diagnostics or laboratory skills.
Culture & Benefits
- Collaborative, high-performing environment with an emphasis on in-person engagement.
- Annual cash bonus, long-term equity incentives, Employee Stock Purchase Plan, and 401(k) with a 4.5% company match.
- Medical, dental, vision, FSA, HSA, life, disability, legal, pet, and other insurance programs.
- Paid time off, company holidays, paid winter break, sick time, and paid parental leave.
- Onsite gym, parking with electric vehicle charging, Caltrain shuttle, subsidized lunches, and stocked breakrooms.
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