1 день назад
Clinical Research Leader (Neurovascular)
109 000 - 174 800$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Leader (Neurovascular): Leading and supporting company-sponsored clinical trials for neurovascular medical devices with an accent on clinical trial execution, evidence generation, regulatory compliance, and safety management. Focus on developing trial documentation, coordinating sites and cross-functional stakeholders, reviewing clinical data, and delivering projects on time, within budget, and in compliance with regulations.
Location: Irvine, California, United States; remote work may be permitted at management discretion
Base pay: $109,000–$174,800 per year
Company
Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare and neurovascular solutions for hemorrhagic and acute ischemic stroke.
What you will do
- Lead and support one or more company-sponsored neurovascular clinical trials from feasibility and site selection through closeout.
- Develop and maintain clinical trial protocols, informed consents, case report forms, monitoring plans, study manuals, investigator brochures, and required reports.
- Coordinate clinical trial sites, investigators, IRBs/ECs, vendors, CRAs, contractors, and cross-functional partners.
- Manage clinical data review, trial registration, investigational device accountability, investigator agreements, trial payments, and study budgets.
- Contribute to global evidence generation, post-market clinical follow-up, regulatory strategy, publications, and promotional material review.
- Coordinate clinical safety activities, including adverse-event reporting, safety reviews, safety boards, and study safety management plans.
Requirements
- Bachelor’s degree in life science, physical science, nursing, biological science, or a closely related field.
- At least 6 years of relevant experience with a BS, 5 years with an MS, or 3 years with a PhD preferred.
- Previous clinical research or equivalent experience and experience working with cross-functional teams.
- Strong understanding of clinical research processes, product development, healthcare markets, clinical trends, and global clinical trial regulations.
- Strong presentation, technical writing, written English, and oral English communication skills.
- Advanced project management skills, ethical professional conduct, and the ability to manage multiple projects.
Nice to have
- Medical device experience.
- Clinical or medical background.
- Relevant certifications such as CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, or MEDDEV.
Culture & Benefits
- Inclusive work environment focused on respect, dignity, diversity, and individual merit.
- Vacation, sick time, holiday pay, and work, personal, and family time.
- Parental, bereavement, caregiver, volunteer, and military spouse leave programs.
- Work arrangement may be remote at management discretion.
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