Clinical Research Project Leader

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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 https://www.jnj.com/medtech

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-relate...