clinical research manager.

Operating with minimal supervision, you will lead and support one or several clinical trials within the Clinical R&D Department. You will serve as the primary clinical representative across multi-disciplinary teams and maintain strong relationships with trial sites.

• Trial Management: Lead the feasibility, selection, setup, conduct, and closure of clinical trials across assigned countries in accordance with ICH-GCP, local regulations, and company SOPs.
• Document & Data Development: Draft and review key trial documentation (study protocols, informed consents, CRFs, monitoring plans, investigator brochures) and oversee clinical data preparation for statistical analysis.
• Site & CRA Oversight: Act as the primary contact for trial sites, oversee Clinical Research Associates (CRAs), and manage investigator agreements, trial payments, and investigational device accountability.
• Safety Coordination: Coordinate safety-related trial activities, develop Safety Management Plans (SMP), liaise with medical safety teams, and manage adverse event reporting.
• Cross-Functional Partnering: Drive evidence generation strategies (EGS) by partnering with Global Strategic Marketing, Medical Affairs, Regulatory Affairs, and R&D.

• Regulatory Affairs
• People Management
• Risicomanagement
• Fasen van Klinisch Onderzoek

• Education: Minimum Bachelor’s degree in Life Sciences, Physical Sciences, Nursing, or Biological Sciences.
• Experience:
• 8 to 10 years of general work experience (or BS + 6 yrs / MS + 5 yrs / PhD + 3 yrs of relevant clinical research experience).
• Demonstrated hands-on experience independently running clinical trials, ideally within a MedTech or medical device environment.
• Technical Knowledge & Certifications:
• Strong knowledge of clinical research processes, GCP, and device regulations (MDR, ISO 14155, MEDDEV).
• Relevant certifications (e.g., CCRA, CCRC, CCRP, RAC) are a strong plus.
• Languages: Fluent written and spoken English; additional European languages are an asset.
• Location & Travel: Based in Belgium, flexible to work hybrid in Diegem (typically 3 days onsite / 2 days remote), and willing to travel (~20%, primarily EMEA site qualification visits).