(Senior) Clinical Research Manager ( 2 positions)

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:
People Leader

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 2 opened positions as a (Senior) Clinical Research Manager to be based in Diegem, Belgium.

Purpose:

The Clinical Research Manager will be responsible for pre- and/or post-market clinical trial management within the Clinical R&D Department of J&J MedTech Electrophysiology

TASKS AND REPSONSIBILITIES

In accordance with all applicable guidelines, laws/regulations and J&J procedures, this position


* Serves as a Clinical Research Manager to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.


* Leads in study design to develop appropriate clinical trials to meet clinical evidence needs.


* Manages end-to-end strategic and operational oversight of clinical trials, from submission strategy, protocol development to final clinical study report.


* Direct and coordinates activities on submission and approval of clinical studies to country authorities.


* Manages the feasibility, selection, set up, conduct and closure of clinical trials within the allocated countries.


* Ensures compliance with the European Medical Device Regulation (MDR)


* Accountable for completion of clinical trial reports and data management safety activities.


* Manages and oversees ordering, tracking, and accountability of investigational products and trial materials.


* Ensures applicable trial registration (e.g.

www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.


* Ensures timely clinical data review, data readiness for analysis, and statistical analysis in cooperation with relevant groups


* Ensures availability of study outcomes for applicable study reports and publications.


* Works with all relevant Clinical R&D and cross-functional partners (e.g.

Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Ac...