11 часов назад
Associate Director, Clinical Operations (Ophthalmology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Clinical Operations (Ophthalmology): Developing strategies and managing worldwide clinical trials for investigational ophthalmic devices with an accent on study planning, clinical documentation, regulatory compliance, and cross-functional collaboration. Focus on managing timelines, resources, budgets, CRO partnerships, and multiple studies while mentoring study managers and improving clinical trial processes.
Location: Hybrid work from the Jacksonville, Florida office, United States; up to 10% business travel may be required.
Company
Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare solutions, including vision treatments and ophthalmic devices.
What you will do
- Develop strategies for complex clinical issues and manage the strategic elements of worldwide clinical trial conduct.
- Own clinical trial plans, timelines, resource plans, budgets, agreements, and statements of work.
- Prepare and finalize clinical protocols, informed consent forms, case report forms, training materials, and other study documents.
- Ensure trials follow operating procedures, company policies, Good Clinical Practice, and applicable regulations for investigational ophthalmic devices.
- Select and manage contract research organizations, including contracts, timelines, and budgets.
- Lead process improvements, foster cross-functional collaboration, and mentor study managers across multiple clinical studies.
Requirements
- Bachelor’s degree or higher.
- At least 8 years of clinical research experience in a regulated medical device or pharmaceutical industry.
- Understanding and application of clinical research principles, procedures, and Good Clinical Practice.
- Strong communication, organizational, interpersonal, negotiation, and influencing skills.
- Ability to work in a hybrid arrangement from the Jacksonville, Florida office.
Nice to have
- Master’s or PhD in a scientific discipline.
- At least 2 years of experience as a clinical research associate.
- People management experience.
- Knowledge of ophthalmology and medical devices or instrumentation used in ophthalmic surgery.
- Technical knowledge across operations, quality assurance, laboratory, regulatory, and project management functions.
Culture & Benefits
- Inclusive work environment focused on respecting employee diversity and dignity.
- Opportunity to contribute to vision treatments and solutions designed to improve healthy sight throughout patients’ lifetimes.
- Cross-functional collaboration and innovation across Johnson & Johnson companies.
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