Clinical Research Specialist

Il y a 1 mois

Vilvoorde, Flemish Region, Belgique Randstad Temps plein

Clinical Research Specialist – MedTech (Electrophysiology)

Are you passionate about advancing healthcare technologies and driving breakthrough clinical studies? Join a global leader in medical technology as a Clinical Research Specialist focusing on innovative Electrophysiology solutions. In this high-impact role, you will bridge the gap between cutting-edge clinical R&D and hands-on medical applications in hospitals across the EMEA region. If you thrive in a dynamic, collaborative environment where your work directly touches patient lives, we want to hear from you


Job Content

As a Clinical Research Specialist, you will support the end-to-end execution of company-sponsored clinical trials within our client's MedTech Electrophysiology division. Working under general guidance within the Clinical R&D department, you will build strong collaborative relationships with trial sites, physicians, ethics committees, and cross-functional internal teams.

From guiding hospital teams in the lab and managing ethical and regulatory submissions to handling clinical safety coordination and data reviews, you will serve as a trusted, knowledgeable cornerstone for allocated clinical studies.


Key Responsibilities

  • Study Execution & Site Management: Support trial feasibility, site selection, initiation, conduct, and close-out in compliance with ICH-GCP, local legislation, and company SOPs. Act as the primary contact for clinical trial sites and Clinical Research Associates (CRAs).
  • On-Site & Lab Support: Work directly in hospital settings and labs alongside physicians to ensure procedural protocol compliance, data collection, and site qualification.
  • Documentation & Submissions: Assist in developing study protocols, informed consent forms, CRFs, monitoring plans, and annual reports. Handle regulatory and ethical submissions.
  • Safety & Regulatory Coordination: Coordinate study safety activities, safety management plans (SMP), adverse event reporting, and safety board meetings across cross-functional teams.
  • Device & Trial Material Tracking: Oversee the ordering, tracking, accountability, and inventory of investigational devices and trial materials.
  • Project & Data Management: Track assigned project budgets, oversee investigator agreements and payments, and assist in clinical data reviews to prepare data for statistical analyses and publications.


Job Requirements

Education & Experience

  • Education: Minimum of a Bachelor’s degree preferably in Life Science, Physical Science, Nursing, or Biological Science (Master’s or PhD is a plus).
  • Experience: Minimum of 2 years (BS) or 1 year (MS/PhD) of relevant clinical research experience, preferably within medical devices.
  • Location: Must be based in Belgium, with the willingness and flexibility to travel across the EMEA region (~20% travel).

Skills & Competencies

  • Technical Knowledge: Strong understanding of clinical research processes, global trial regulations, and standard operating procedures (ICH-GCP, ISO 14155, MDR).
  • Software Proficiency: High proficiency in Microsoft tools, particularly Excel.
  • Mindset & Style: Assertive, independent worker who communicates proactively and thrives under minimal supervision for routine tasks.
  • Languages: Fluent in English (written and spoken). Proficiency in any additional European language is an advantage.
  • Certifications: Relevant industry certifications (e.g., GCP, CCRA, CCRC, CCRP, RAC) are preferred.


What We Offer

  • Our Offer (Employed Consultant)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