Clinical Trial Project Manager

☞ Gabi SmartCare

Ver: 140

Dia de atualização: 16-11-2025

Localização: Mont-Saint-Guibert Walloon Brabant

Categoria: Outro

Indústria:

Tipo de empregos: Full-time

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Conteúdo do emprego

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
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Data limite: 31-12-2025

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