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Associate Director, Clinical Trials Management – Neurovascular/Specialty
Clinical Trial Administration
Requisition ID: 0307170914
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Associate Director, Clinical Trials – Neurovascular/Specialty for Cerenovus located in Irvine, Ca. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular, Surgical and Non-Surgical Aesthetics, and Reprocessing.
CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
This individual will be responsible for clinical trial management within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the liaison with the Clinical R&D Franchise for projects under his/her responsibility.
The Associate Director – Clinical Trials Manager will:
• Serve within the Clinical R&D Operations CoE group to execute company sponsored clinical trials for the Medical Device Franchises
• Manage all operational activities of assigned clinical trials/programs within the Clinical R&D Operations group
• Serve as the liaison to the Clinical R&D Franchise and Clinical R&D BSDM for projects/trials/programs under his/her responsibility and may serve as a member of the clinical trial/study/program core team
• Serve as a contact for clinical trial sites
• Solve problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed
• Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
• 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
• Be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
• Plan, track and manage 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
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
· Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
· BS with at least 10 years, MS with at least 8 years, PhD with at least 6 years of relevant experience preferred.
· Minimum of 2 years people management is required.
· Knowledge of Good Clinical Practices(GCP) is required.
· Significant previous experience in clinical project leadership across multiple studies/programs required.
· Experience with budget planning, tracking and control required.
· Clinical/medical background a plus is a preference
· Experience with neurovascular clinical trials is preferred.
· Up to Travel up to 20%
· Performs other related duties as required.
Depuy Orthopaedics. Inc. (6029)
Clinical Trial Administration