Clinical Project Manager (Science)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Clinical Project Manager (Science): Managing multi-center site activities and ensuring compliance with protocols, ICH GCP, and regulatory requirements with an accent on independent study management. Focus on leading initiation and close-out activities, coordinating external vendors, and overseeing study plans.
Location: Remote (Must be based in the United States)
Company
is committed to swift, exceptional clinical research through translational medicine to help get drugs to market faster.
What you will do
- Lead initiation, maintenance, and close-out activities for multi-center studies in accordance with protocols and GCP.
- Plan and procure team resources to complete study activities according to scope, budget, and timeline.
- Develop and oversee study plans, including project management, risk management, data management, and safety plans.
- Coordinate activities with central laboratories and other external service providers or vendors.
- Review and negotiate site budgets and contracts, including the development of change orders.
- Maintain effective communication with sponsors and internal departments to ensure successful project completion.
Requirements
- Must be based in the United States (home-based).
- Ability to travel approximately 30%, primarily in the US and occasionally to Europe.
- Proven experience in the independent management of multi-center site activities.
- Strong knowledge of ICH Good Clinical Practices (GCP) and regulatory requirements.
- Flexibility in scheduling to accommodate an international footprint.
Culture & Benefits
- Work environment based on values of Integrity, Trust, Teamwork, and Respect.
- Full-time employment with a remote work setup.
- Equal Opportunity Employer commitment.
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