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 Access, R&D, Clinical Science and External Research etc.) identifying clinical evidence needs and delivering relevant clinical data reports. + Serves as the clinical representative on a New Product Development team. + Plans, tracks and manages assigned project budgets to ensure adherence to business plans. + Is responsible for the development of Post-Market Clinical Follow-up (PMCF) Plans and Reports. + Takes ownership during internal and external audits. + Manages resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency. + Responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development. + Ensures compliance of all safety-related activities of clinical trials + Has a strong understanding of company products and therapeutic area + Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed. + 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** + A minimum of 8 years’ clinical research related experience + Experience in clinical project leadership across multiple studies, programs and working with cross-functional teams + Experience with project management for the full lifecycle of clinical studies + 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 + Self-learning