Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Staff Clinical Project Leader (CRA), 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 Staff Clinical Project Leader will:
- Serve as a Staff 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/program 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
- Independently solves problems 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
- Plan, track, and manage assigned clinical trials/programs 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
- Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
- Ensure that all Human Resource related activities, and decisions embody the Johnson & Johnson Credo Values.
- Provide strong 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.
- Manage and mentor Clinical Trial Leaders/Senior Clinical Trial Leaders, as applicable.
- Responsible for the training, performance management, and development of clinical staff, as applicable.
- Accountable for quality, compliance with regulations and company procedures, resource requirement, timelines and budgets for assigned clinical projects, including those assigned to direct reports.
- May lead clinical studies and/or programs that may involve multiple study managers/leaders and CROs (>300k USD annual investment).
- Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies.
- May support Senior CTM or CTM within a large or complex regulated clinical study/program.
- Exhibit proficiency and act as a Subject Matter Expert in clinical trials involving complex design issues. May provide solutions and guidance on complex situations.
- May manage work done by CROs under CTM/Senior CTM guidance.
- Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, cost-effective, and high quality execution of assigned clinical studies/programs, including those assigned to direct reports.
- Independent decisions for most situations, but may require guidance for to complex situations. Minimal supervision needed.
- Reviews and provides feedback on clinical operation section of protocols with minimal supervision.
- Understand business value and balance overall business objectives and functional needs.
- Requires knowledge of Good Clinical Practices
- Knowledge and understanding of application of regulations and standards applied in clinical areas/regions.
- Effective leadership skills in a professional and ethical manner
- Strong Written and oral communication skills
- Demonstrated competencies in the following areas are required:
- Behave and lead in a professional and ethical manner
- Presentation skills and influencing of others
- Advanced technical writing skills
- Advanced project management skills with ability to handle multiple projects
- 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 6 years of experience, MS with at least 5 years of experience, or a PhD with at least 3 year of relevant experience is required
- Previous experience in clinical trial management or equivalent is required
- Experience working well with cross-functional teams is required
- Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE)
- Experience managing others is preferred
- 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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