Are you an experienced Clinical Research Specialist seeking your next challenge in the MedTech sector? We are seeking a proactive, assertive, and communicative professional to join our dynamic team of 40 experts. You will play a key role in supporting and executing large-scale clinical trials (pre- and post-market), particularly within cardiology and electrophysiology, ensuring the highest standards of compliance and project delivery.
Key Responsibilities
* Clinical Trial Management: Lead and support the feasibility, site selection, setup, conduct, and closure of company-sponsored clinical trials in accordance with ICH-GCP, ISO 14155, MDR, MEDDEV, and SOPs.
* Documentation & Compliance: Contribute to the development of study protocols, informed consents, CRFs, monitoring plans, investigator brochures, annual reports, and trial registration on platforms
* Site Collaboration: Serve as the primary contact for clinical trial sites; collaborate with site personnel, IRBs/ECs, vendors, and internal teams.
* Project Coordination: Oversee investigational device ordering, tracking, and accountability; support trial payments and investigator agreements.
* Data Review: Conduct clinical data review to prepare for statistical analyses and publications.
* Monitoring Activities: Perform site qualification, initiation, interim, and close-out visits as required.
* Safety Coordination: Manage all safety-related activities for clinical trials, including adverse event reporting, safety board meetings, and safety management plans.
* Mentorship & Leadership: Mentor junior team members and lead small study teams to deliver critical milestones.
* Continuous Improvement: Actively participate in process improvement initiatives and global evidence generation/dissemination strategies.
Requirements
Education
* Bachelor’s degree (minimum), preferably in Life Science, Physical Science, Nursing, or Biological Science.
Experience
* BS with 4+ years, MS with 3+ years, or PhD with 2+ years of relevant clinical research experience.
* Proven expertise in clinical research (pre- and post-market), ideally with experience in MedTech and large multicenter trials.
* Project management experience in clinical research is required.
* Pharmaceutical background is mandatory; medical device experience is highly preferred.
* Experience in cardiology or electrophysiology studies is a significant advantage.
* GCP training and knowledge of clinical research principles.
* Relevant certifications (CCRA, CCRC, CCRP, RAC, etc.) are an advantage.
Skills & Competencies
* Excellent understanding of global clinical trial regulations and clinical research processes.
* Strong technical writing and presentation skills.
* Outstanding communication skills in English (spoken and written); additional languages are a plus.
* Ability to work independently on complex projects and collaborate effectively with multidisciplinary teams.
* Flexibility, proactivity, assertiveness, and strong prioritization skills.
What can you expect?
* Company car and net expense allowance: You will receive a competitive salary package that includes a company car
* Opportunities for training and development: Arcadis offers a wide range of internal and external training opportunities to help you expand your expertise and advance your career.
* International network: Become part of a worldwide network of professionals and collaborate with colleagues and clients from across the globe.
* Innovation and sustainability: Contribute to innovative and sustainable projects that truly make a difference.
Choosing Arcadis means a dynamic work environment, interesting projects, and excellent opportunities for personal and professional growth!
Join Arcadis. Create a Legacy.