Senior Clinical Trial Leader

Company: Johnson & Johnson
Location: Raynham
Posted on: June 6, 2021

Job Description:

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies is currently recruiting for a Senior Clinical Trial Leader to be located in Raynham, MA, Warsaw, IN, West Chester, PA, Cincinnati, OH, Irvine, CA. DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com. This individual will be responsible for leading one or several clinical trials within the Clinical R&D Operations, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution. Position duties & responsibilities: Serve as a Senior Clinical Trial Leader within the Clinical R&D Operations group to execute and manage activities for assigned company sponsored clinical trials for the Medical Device Franchises Serves as a member of the clinical trial/study core team, primary contact for clinical trial sites, and the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility Solves problems with support from Clinical Management arising during clinical study execution, and will seek mentorship for more sophisticated 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 business partners 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 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 results Business Leadership Responsibilities: Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials May 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) May 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 Reviews and provides feedback on clinical operation section of protocols with supervision May plan budgets for single trials with supervision Functional and Technical Competencies: Requires understanding of Good Clinical Practices Understanding and application of regulations and standards applied in clinical areas/regions is required Good presentation skills and effectively influencing of others Written and oral communication skills Technical writing skills Leadership Competencies: Leadership required in alignment with J&J Leadership Imperatives: Develop collaborative relationships with key internal and external business partners, principally within allocated study teams and department and wherever possible across the business, as well as the resources providers and vendors to create a strong and productive partnership Take ownership for development of self and engage in transparent and constructive conversations 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 Participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer Perform other related duties as required Qualifications Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required BS with at least 4 years, MS with at least 3 years, PhD with at least 1 years of relevant experience preferred Previous experience in clinical trial management or equivalent is required Relevant industry certifications preferred (i.e., CCRA, RAC, CDE) Clinical/medical background a plus Medical device experience a plus Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Primary Location United States-Massachusetts-Raynham-325 Paramount Drive Other Locations North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-California-Irvine, North America-United States-Pennsylvania-West Chester Organization Medical Device Business Services, Inc (6029) Job Function R&D Requisition ID 2105936516W

Keywords: Johnson & Johnson, Brockton , Senior Clinical Trial Leader, Other , Raynham, Massachusetts