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Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research – Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Diegem, Flemish Brabant, Belgium
Job Description:
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at
We are searching for the best talent for a Clinical Research Project Leader to be based in Diegem, Belgium.
Purpose :
Responsible for leading and coordinating pre- and/or post-market clinical trials within the Clinical R&D Department of J&J MedTech Electrophysiology
TASKS & RESPONSIBILITIES
In accordance with all applicable guidelines, laws, regulations and J&J procedures, this position
- Serves as a Clinical Research Leader to coordinate and execute pre- and/or post-marketing company sponsored clinical trials, ensuring compliance with timelines and study milestones.
- Coordinates and executes on feasibility, selection, set up, conduct and closure of clinical trials within the allocated countries
- Coordinates and executes activities on submission and approval of clinical studies to country authorities.
- Ensures compliance with the European Medical Device Regulation (MDR)
- Develops clinical trial documents (e.g. study protocol, informed consents, CRF, safety management plan, monitoring plan, study manual, investigator brochure, annual reports)
- Ensures applicable trial registration (e.g. on www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed
- Coordinates development and execution of participation site contracts and trial payments
- Coordinates site preparation and planning for study procedures (lab installation, case attendance)
- Coordinates ordering, tracking, and accountability of investigational devices and trial materials
- Leads and mentors all resources assigned to designated clinical studies
- Supports budget planning and ensures proper tracking and management of assigned project budgets to ensure adherence to business plans
- May perform supporting on-site activities including site qualification and initiation visits, and project-related guidance
- Coordinates study-related committee meetings and reporting (e.g. DMC, CEC, advisory committee)
- Ensures timely completion of clinical trial reports and data management safety activities.
- Ensures timely clinical data review and ensures data readiness for analysis.
- Coordinates and cooperates with the statistical and programming groups on study-outcome generation and review
- Plans, tracks and manages assigned project budgets to ensure adherence to business plans.
- Involved in the development of Post-Market Clinical Follow-up (PMCF) Plans and Reports.
- Provides support during internal and external audits.
- Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.
- Coordinates all safety-related activities of clinical trials
- Has a strong understanding of company products and therapeutic area
- Performs other duties assigned as needed
EDUCATION, EXPERIENCE AND SKILLS
Education
- Minimum of a bachelor's degree in science, medical or other relevant education
Experience
- Minimum of relevant clinical research related experience: Bachelor 6 years, Master 5 years, PhD 3 years
- Experience in clinical project management and working with cross-functional teams
- Experience with budget planning, tracking and control
- Knowledge of clinical research applicable guidelines and regulations e.g. GCP, ISO 14155, MDR, …
- Experience in medical device clinical research
Skills:
- Strong presentation and technical writing
- Excellent written and oral English communication
- Strong leadership and team management
- Planning and Organization
- Time-management
- Adaptability
- Problem-solving