PlusOne

Clinical Project Manager - Medical Devices - Walloon Brabant

GABI SMARTCARE

Gabi SmartCare is a Belgian medtech company dedicated to transforming pediatric care.

They offer healthcare professionals, researchers, and families an innovative, patient-centric digital solution with personalized data and predictions to improve children’s care (better monitoring, diagnosis, and prevention).

Clinical Project Manager

The clinical project manager will:

- be responsible of clinical projects linked to US and EU technical files submissions

- manage the daily operations of clinical trials, including budget, policies and clinical procedures preparation.

- participate in global strategy of the company

Key responsibilities

· 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.

· Clinical strategy presentation to the board

Required skills, education & experience

· Bachelor’s or Master’s degree in health or life sciences, or in a related field (or equivalent experience),

· Valid GCP certificate.

· 5+ years within medical industry, with extensive experience with medical device (class II or III)

· Experience with FDA (Presub, 510(k) submission…)

· Experience in startups

· Experience with CRO management

· Experience with quality management system ISO 13485

· Fluent in French and English, Dutch is a plus

Reports to

· Design & Development Manager.

Back Up

· Design & Development Manager.

Offer

Attractive salary and company car with fuel card

Meal vouchers

Hospitalisation insurance

Publication date

22.11.2021

Contact person

Van De Woestijne

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