Clinical Research Manager Biosense Webster

Jobinhalt

Working with Johnson & Johnson can change everything. Including YOU. In this exciting role as Clinical Research Manager within our Biosense Webster team you are responsible for the clinical trial strategy and management within the Clinical and Medical group of Biosense Webster, working with cross-functional teams across the organization and cooperating with expert physicians and hospitals on the treatment of patients with cardiac arrhythmia. Office location: Diegem, Belgium Contract type: full-time permanent position Reports to: Director Clinical Research Your role’s purpose: Management of company sponsored clinical trials on cardiac medical devices, ensuring compliance with timelines and study milestones Leads in clinical study design to develop appropriate clinical trials to meet the clinical evidence needs Has oversight of all aspects of a clinical trial, from design to closure, in accordance with the ICH-GCP, applicable country legislations and Company Standard Operating Procedures Is responsible for collaboration with key opinion leaders, investigators, IRBs/ECs, contractors/vendors, societies, associations and company personnel; Is responsible for clinical data review to prepare data for statistical analyses and publications; Contributes to the development and delivery of appropriate Global Evidence Generation and Dissemination Strategies to support New Product Development and Product Life-Cycle Management , in cooperation with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc) Plans, tracks and manages assigned project budgets to ensure adherence to business plans; Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections; Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports; Manages and mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency; Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed. Qualifications We would love to hear from YOU, if you have: Must haves: to be considered for this role, please ensure the minimum requirements are evident on your resume. Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science. + 8 years related scientific/ technical experience, including leadership/ management role within Clinical Research. Significant previous experience in clinical project leadership across multiple studies/ programs Experience working well with cross-functional teams Experience with budget planning, tracking and control Nice to have: Clinical/medical background People management experience Medical device experience highly preferred Experience in electrophysiology Are you ready to make an impact? If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work. We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. About Johnson & Johnson At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why a we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Belgium are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! About Biosense Webster, Inc., part of J&J Medical Devices Companies At Biosense Webster we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes. Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, and will not be discriminated against on the basis of disability. Ready to be part of something great? Apply now. We want YOU! Primary Location Belgium-Brussels-Capital Region-Diegem- Organization Johnson & Johnson Medical NV (7546) Job Function R&D Requisition ID 2105956370W