Johnson & Johnson Services, Inc.
Associate Director Clinical Trials Management /Cardiovascular The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for an Associate Director - Clinical Trials Management/Cardiovascular, located in Irvine, CA. The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Biosense Webster (BWI), CNV Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing. 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 Qualifications 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 is required. Clinical/medical background is preferred. Cardiovascular background, preferably with Electrophysiology is preferred. Travel up to 20% is required. Performs other related duties as required. Primary Location United States-California-Irvine Organization Depuy Orthopaedics. Inc. (6029) Job Function Clinical Trial Administration Requisition ID 9590170901
Johnson & Johnson Services, Inc.
Website : http://www.jnj.com
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