Do you enjoy building up and managing clinical activities related to healthcare? Do you have experience with medical devices and the standards that apply to them? Do you want to impact millions of lives? Do you want to be surrounded by great colleagues in a growing company?
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
Ready to transform pediatric care with us? Please send your CV (in English) to Edouard (email@example.com).