Based in Gembloux, Intressa Vascular is a clinical-stage company developing the innovative solutions to address life-threatening cardiovascular conditions such as aortic dissection.
Their mission is to help physicians address the devastating effect of aortic dissections by providing next-generation endovascular treatment. For additional information about the company, please visit https://intressavascular.com/
In order to strengthen the clinical team in Gembloux, we are looking for a Clinical Project Manager (M/F).
Reporting to the VP Clinical Affairs, and working closely with Medical and Regulatory Affairs, you will be responsible for the collaborative, compliant and timely management of the assigned clinical projects which are at the heart of the company’s strategy and development roadmap.
Your main responsibilities are:
- Lead the cross-functional Clinical Project Team and represent it on the Program meetings.
- Manage clinical projects, including development, review and approval of clinical documentation (e.g. protocols, investigator’s brochure), identification and selection of sites and service providers, EC/CA submissions, and regulatory reporting.
- Ensure continued oversight and management of the sites and service providers.
- Ensure timely and adequate safety documentation, review, and reporting (AEs and DDs).
- Keep the TMF up-to-date at all times, providing guidance to the Clinical Assistant as required.
- Ensure continued project compliance with laws and regulations, applicable SOPs, study protocols, and manuals.
- Facilitate transversal communication and cross-functional interaction within teams.
- Contribute to the company's inventive step to develop, secure, and protect company's know-how, trade secrets and intellectual property assets.
- Degree in Health Sciences, Life Sciences, or related medical/scientific field preferred. Relevant work experience may be considered in absence of degree.
- A minimum of 5 years of experience in the management of medical device studies, including of Contract Research Organization (CRO).
- In-depth practical knowledge of Good Clinical Practice (ISO14155) and clinical research regulations.
- Keen interest in scientific and technical issues related to clinical study.
- Strong problem-solving and critical thinking skills, attention to details.
- Proactive, flexible, team player, with excellent organizational, time management and communication skills.
- Able to work and collaborate effectively with internal and external actors to achieve company objectives.
- Fluent in English, written and spoken. A good command of any other language is an asset.
- A challenging position with a high potential innovative medical device company.
- Working in a human-sized, collaborative, and respectful environment
- A variety of interesting contacts with international exposure.
- An attractive compensation package in line with the position’s responsibilities and your experience.
Please send your CV together with an adapted cover letter via https://www.pahrtners.be/fr/offres-demploi/clinical-project-manager-mf/ or to email@example.com.
Your application and related information you would share will remain strictly confidential.