Job Description

CRA RESOURCE LEADER US at J&J Family of Companies in Boise, Idaho, United States Job Description CRA RESOURCE LEADER US - 2306155179W Description Description - External Medical Device Business Services, part of 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. Medical Device Business Services is currently hiring for a CRA Resource Leader. This role can be remote based in the United States. Summary The CRA Resource Leader is responsible for the resource management of monitors. Key Duties/Responsibilities Responsible for the direct reports, contractors, and functional sources contracting, training, and performance Allocate and ensure efficient use of resources (direct reports, contractors, functional resources) for projects to provide quality deliverables while maintaining optimal efficiency and cost effectiveness for all assigned clinical operations activities across all franchises Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance Responsible for defining and administering budgets for contract and functional sourced monitoring services Perform accompanied site visits to assess and ensure quality and efficiency of monitoring resources and their oversight Participate in project management meetings and provide an overview of monitoring resources quality and workload on a regular basis Identify and assure strategies, resources, and accountabilities are in place to achieve rapid, cost-effective, and well-executed clinical studies in assigned territories: In collaboration with regional CTMs and CTLs, manage all monitoring sourced clinical functions within the Clinical R&D Operations; Allocate Resources to projects to provide quality deliverables while maintaining optimal efficiency; and communicate effectively with monitoring vendors (CRO, Functional Service providers etc.) Participate in Clinical Study Core team meetings, as required, and provide an overview of monitoring resource staff quality and workload Provide internal communication of important clinical data and event Establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders Participate in departmental initiatives aimed at improving process and efficiency, in particular for the development and optimization of global processes to the overall benefit of the Clinical R&D Operations Provide technical support in preparation for site and incoming audit. May be involved in other tasks to support Clinical R&D Operations and Franchise Clinical R&D, as needed Qualifications Qualifications Required Education & Skills/Experience: A minimum of a BA/BS Degree A minimum of 8 years relevant experience in the healthcare field or an advanced degree with at least 6 years of relevant experience A minimum of 2 years supervisory experience managing clinical monitors At least 3 years of monitoring experience Understanding and application of US regulations and standards applied in clinical areas and MedTech/combination products Strong knowledge of current clinical regulations, standards, and good clinical practices Considerable knowledge of monitoring and site management processes and skilled in the management of monitoring resources. Experience providing oversight and guidance for multiple projects and focus areas simultaneously (ability to manage multiple tasks and be detail oriented) Strong leadership and mentoring Familiarity and experience with Change Management Strong presentation and influencing skills Excellent written and oral communication skills are required. Preferred Education & Skills/Experience: Advanced degree (M.S., M.E., etc.) is preferred Experience managing external monitors and vendors (i.e., contract and flex supplier monitors and clinical research associates) Relevant industry certifications preferred (i.e., CCRA, RAC, CDE). Clinical/medical background is a plus MedTech and pharma experience a plus CRO monitoring experience a plus Other: This position may require up to 20% domestic and international travel. Remote-based. The base pay range for this position is $111,000 to $185,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, [long-term incentive - include LTI only if applicable] disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below: Primary Location NA-United States Organization Medical Device Business Services, Inc (6029) Job Function Clinical Trial Administration Req ID: 2306155179W To view full details and how to apply, please login or create a Job Seeker account

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