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Senior Clinical Trial Leader_Study Lead
Clinical Trial Administration
Requisition ID: 5475180309
Johnson & Johnson's Family of Companies is recruiting for an Senior Clinical Trial Leader to be located in Irvine, Ca to support our Medical Devices business.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
CERENOVUS is a global leader in neurovascular care. Offering a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke, CERENOVUS is committed to changing the trajectory of stroke.
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.
• Account for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
• 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).
• 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.
• Review and provide feedback on clinical operation section of protocols with supervision.
• Plan budgets for single trials with supervision
• Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science, with at least 4 years is required. An MS with at least 3 years or PhD with at least 1 years of relevant experience is preferred
• Understanding of Good Clinical Practices(GCP) is required.
• Understanding and application of regulations and standards applied in clinical areas/regions is required.
• Previous experience in clinical trial management or equivalent is required.
• Relevant industry certifications, (i.e., CCRA, RAC, CDE) is preferred
• Presentation skills and effectively influencing of others is preferred.
• Written and oral communication skills is required.
• Clinical/medical background is preferred.
• Medical device experience is preferred.
Depuy Orthopaedics. Inc. (6029)
Clinical Trial Administration