
Clinical Project Manager
il y a 2 semaines
Then you might be the **Clinical Project Manager** we are looking for
You, as the Clinical Project Manager, will complete the team responsible of Gabi SmartCare’s clinical projects, both in the EU and the US. You:
- Manage and refine the operational plan of studies (monitoring plan, deadlines, quality),
- Coordinate internal and external clinical development activities and participate in the selection of study sites
- Participate in the writing of the study documentation: study protocol, statistical analysis plan, study report,
- Gather and submit the documentation required to obtain authorizations from the authorities and ethics committees,
- Develop and manage study schedules (including recruitment),
- Organize the training of clinical study teams,
- Participate in PreSub (preparation and meetings) regarding the FDA validation of performance study
- Manage approved budgets throughout the clinical trials,
- Participate in clinical strategy definition of the company
- Ensure compliance with relevant regulations by clinical trial sites by reviewing surveillance reports, GCP audit reports, communications with investigators, study site staff, notified bodies and competent authorities,
- Participate in the implementation of the processes required to ensure the clinical activities comply with GCP and other standards in force.
- Present the cinical strategy to the Board.
- What are we looking for?_
- You have a Bachelor’s or a Master’s degree in health or life sciences (or equivalent experience)
- You hold a valid GCP certificate
- You have previously worked in the medical industry (at least 5 years of experience) and have experience with medical devices (class II or III)
- You have a "startup mindset"
- You know how CRO management works
- You are a quality management system master (ISO 13485)
- You know everything about the FDA (presub, 510(k), submission,) or are willing to learn all of it
- You are fluent in French and English, Dutch is a plus
- What do we offer you?_
Gabi SmartCare is a young, growing, and healthy Belgian startup with big ambitions: be the new standard of pediatric care and improve global health.
In addition to a permanent contract and an attractive salary package, we offer you
- the opportunity to develop new skills and to grow with us
- a professional but fun environment with great colleagues
- flexible work hours with a work-life balance
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