Détails du poste
- Contrat
- Indépendant
- Temps de travail
- Temps plein
- Salaire
- competitive gross salary
- Expérience
- Expérience requise· 8–10 ans
Description de l’offre
...
Are you ready to shape the future of cardiac care?
If you thrive on leading complex clinical trials, collaborating with world-class medical experts, and bringing cutting-edge healthcare solutions to life, this is your opportunity. We are looking for a drive-driven Clinical Research Leader to take ownership of high-impact medical device trials from setup to closure. Step into a role where your clinical expertise directly translates to improved patient outcomes worldwide.
The Electrophysiology team specializes in developing innovative technologies to diagnose and treat cardiac arrhythmias. Operating out of Diegem, Belgium, the Clinical R&D Department fosters a collaborative, scientific environment dedicated to executing trials that meet the highest regulatory and safety standards.
Clinical Research ManagerAre you ready to shape the future of cardiac care?
belangrijkste verantwoordelijkheden
Job Content & Key ResponsibilitiesOperating 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.
vaardigheden
Regulatory AffairsPeople ManagementRisicomanagementFasen van Klinisch Onderzoekkwalificatie
- 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).
voordelen
What We OfferOur offer:
- Competitive gross salary with 13th month and double holiday pay
- Monthly net allowance
- Meal vouchers & eco vouchers
- Choice between company car with fuel/charging card (SalSa plan) or mileage reimbursement for using your own car
- Hospitalization insurance from day 1 + optional outpatient insurance (incl. dental care)
- Group insurance (pension savings)
- Cafeteria plan (Flex Income Plan)
- 4 weeks of statutory holiday + 12 ADV days + seniority leave
- Possibility to work from home (depending on project)
- Benefits at Work discount platform
- Referral bonus when you recommend a new colleague
- Personal follow-up via account manager, HR/L&D support, access to training, learning tools and certifications
- Networking events and internal activities to stay connected with colleagues and the organisation
Prefer to work as a freelance consultant?
- We pay your invoices on time and correctly (30 days)
- Our team of recruiters and account managers is closely involved in your career and follows you up
- Towards the end of your project, we proactively look for your next assignment
Origine et disponibilité
Source : randstad.be. L’annonce peut évoluer ou être pourvue après sa collecte. Confirmez les conditions auprès du recruteur.
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