||Johnson & Johnson
||West Chester, PA United States
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Clinical Research Manager, TECA |
Johnson & Johnson Medical Devices Companies is recruiting for a Clinical Research Manager, TECA, located in West Chester, PA or Zuchwil, Switzerland.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
In this role as Clinical Research Manager, TECA within the Preclinical, Clinical Medical team, this individual has a strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects.
- Contribute to the development and delivery of global EGS / EDS to support NPD and LCM within the assigned projects
- Ensure input and strong alignment from market leads of strategically important countries/regions in the development of the EGS / EDS
- Lead in study design to develop clinical trials to meet the NPD / LCM needs
- Partner with internal partners to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
- Lead interpretation and dissemination of all evidence generated, based on EDS, including reports, abstracts, manuscripts, Clinical Evaluation Reports, etc
- Support the collaboration with investigators to deliver and disseminate evidence
- Write high quality clinical documents to support the development, regulatory approval, and maintenance of our products. Documents include clinical protocols, investigator’s brochures, post-market clinical follow-up plans and clinical study reports, as well as detailed summaries of efficacy and safety and responses to health authority questions
- Interpret and summarize statistical and medical information with an attention to detail to design clinical trials and report study data
- Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization
- Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc
- Cultivate strong relationships with external partners to shape and influence relevant policies
- Develop a strong understanding of the pipeline, product portfolio and business needs
- A minimum of a Bachelor's degree is required.
- BSc with 7+ years, Master’s with 5+ years, or PhD/MD/PharmD with 3+ years of experience is preferred
Experience and Skills:
- A minimum of 1 year of project management/leadership experience within clinical research is required
- Broad understanding of product development processes, team dynamics, healthcare market environment, and clinical trends is required
- Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects is required
- Consistent track record in delivering clinical programs within clinical/ surgical research setting in compliance to SOPs and regulations is required
- Excellent interpersonal skills and proven ability to partner effectively across internal teams and with external partners is required
- Ability to influence decision-makers to ensure a fully aligned evidence strategy is required
- Experience in effective management of project budget processes is required
- Demonstrated expertise and success in building Medical Affairs, Clinical Research or Research & Development teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas is preferred.
- A minimum of 1 year of people management experience is preferred
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-West Chester-1301 Goshen Parkway
Medical Device Business Services, Inc (6029)