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Clinical Trial Leader_In-house Clinical Study Management Associate
Clinical Trial Administration
Requisition ID: 9368180111
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Clinical Trials Leader, located in Irvine, CA.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Biosense Webster (BWI), Cerenovus, 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 leading one or several clinical trials within the Clinical R&D Operations Center of Excellence (CoE), as well as fostering strong, productive relationships with colleagues across the organization. Serves as a trial leader for clinical trial execution.
The Clinical Trials Leader will:
• Serve as a Clinical Trials Leader within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises under supervision
• Serve 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
• Potentially serve as the primary contact for clinical trial sites
• Manage operational activities of assigned clinical studies within the Clinical R&D Operations group
• Solve problems with support from Clinical Management arising during clinical trial 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
• 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
People Leadership Responsibilities:
• 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.
Business Leadership Responsibilities:
• Account for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
• Lead several non-regulated small clinical trials and/or a small number of non-regulated medium trials that may involve other clinical operations staff (i.e., <150K USD annual investment).
• Assist with the management of large regulated or complex trials under supervision.
• Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Perform other related duties as required.
• Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science.
• 2-4 years of relevant experience (or equivalent) is required.
• Experience in clinical trial management or equivalent is preferred.
• Relevant industry certifications i.e., CCRA, RAC, CDE, is preferred
• Experience in clinical/medical background is preferred.
• Medical device experience is preferred.
• Understanding of Good Clinical Practices is required.
• Understanding and application of regulations and standards applied in clinical areas/regions is required
• Presentation skills and influencing of others is preferred.
• Written, oral communication and technical writing skills are required.
Depuy Orthopaedics. Inc. (6029)
Clinical Trial Administration