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.
A recent acquisition within The CSS Group is Coherex Medical, a company focused on the development of a unique device for the treatment of patients diagnosed with atrial fibrillation and at risk for stroke.
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.
This individual will be responsible for leading one or several clinical trials within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution.
The Senior Clinical Trial Leader will:
- Serve as a Senior Clinical Trials Leader within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises
- Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
- Serves as a member of the clinical trial/study core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility
- May serve as the primary contact for clinical trial sites
- Solves problems with support from Clinical Management arising during clinical study execution, and will seek guidance for more complex problems, as needed
- Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
- Track assigned projects budgets to ensure adherence to business plans
- Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
- Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
- Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
- Ensure that all Human Resource related activities, and decisions embody the Johnson & Johnson Credo Values.
- Provide leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
- Ensure efficient use of resources within the clinical study/program to provide high quality deliverables.
- Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
- May lead several small/medium clinical trials (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve other clinical operations staff (i.e., >250K USD annual investment).
- May assist with the management of large regulated or complex trials/program under supervision of CTM or Senior CTM.
- Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities.
- Reviews and provides feedback on clinical operation section of protocols with supervision.
- May plan budgets for single trials with supervision
- Requires understanding of Good Clinical Practices
- Understanding and application of regulations and standards applied in clinical areas/regions is required.
- Good presentation skills and effectively influencing of others
- Written and oral communication skills
- Demonstrated competencies in the following areas are required:
- Leadership in a professional and ethical manner
- Technical writing skills
- 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% travel
United States-California-IrvineOther Locations
North America-United States-California-Diamond BarOrganization
Biosense Webster Inc. (6010)Job Function
Clinical Trial Administration
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