Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Senior Clinical Trial Leader (Senior Clinical Research Associate) for Coherex to be located in either Diamond Bar, CA or Irvine, CA.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing all headquartered in our talent hub in Irvine, CA.
The Senior Clinical Trial Leader will or may be responsible for:
• Clinical study execution within the Cardiovascular & Specialty Solutions group and the overall Clinical Center of Excellence.
• Fostering strong, productive relationships with colleagues within the organization.
• Serving as a member of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility.
• Overall execution of small-medium regulated and non-regulated clinical projects or large non-regulated clinical projects including, but not limited to, study planning, initiation, budget tracking, tracking and supporting subject recruitment, quality of deliverables, site support and study closure.
• Providing support to department wide training.
• Ensuring that all Human Resource related activities and decisions embody the Johnson & Johnson Credo Values.
• Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects.
• Leading several small/medium clinical studies (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff.
• Assisting with the management of large regulated studies under supervision of CPM or Senior CPM and May support CPM and/or Senior CPM within a large or complex clinical study.
• Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities.
• Managing all activities of assigned clinical studies within the Clinical R&D Operations group.
• Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
• Evaluating support requests for publications and to provide consolidated comments and support to the requests.
• Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
• Tracking assigned projects budgets to ensure adherence to business plans.
• Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed.
• Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel.
• Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
• Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies.
A minimum of a Bachelor’s Degree is required, preferably in Life Science, Physical Science, Nursing, or Biological Science.
• MS or PhD is preferred
• A BS with at least 4 years of experience, MS with at least 3 years of experience, or a PhD with at least 1 year of relevant experience is required
• Previous experience in clinical trial management or equivalent is required.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
• Clinical/medical background is preferred
• Medical device experience is preferred
• This position may require up to 30% of domestic travel
United States-California-Diamond Bar
Biosense Webster Inc. (6010)
Clinical Trial Administration
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