Johnson & Johnson Careers
Senior Clinical Trial Leader
Requisition ID: 5991190926
Johnson & Johnson is recruiting for a Senior Clinical Trial Leader located in Cincinnati, OH or Somerville, NJ.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com
You will be responsible for leading clinical study execution on one or several clinical trials within Ethicon Clinical Operations Group, as well as developing strong, positive relationships with colleagues across the organization. Additional responsibilities include:
- Lead all operational activities of assigned clinical studies
- Serves as a member of the clinical trial/study/program core team and as the liaison with the Clinical Franchise and Clinical BSDM team for projects under his/her responsibility
- May serve as the primary contact for clinical trial sites
- Solves problems with support from Clinical Management that arise during clinical study execution, and will seek guidance for more complex problems, as needed
- Provide internal communication of meaningful clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key partners
- May be involved in other tasks to support Ethicon Clinical team as needed
- Plan, track, and lead assigned clinical trials/programs budgets to ensure adherence to business plans
- Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
- May 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
- Lead resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
- Ensure that all Human Resource related activities, and decisions embody the Johnson & Johnson Credo Values.
- Provide leadership/direction 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.
- Accountable for quality, compliance with regulations and company procedures, resource requirement, timelines and budgets for assigned clinical projects.
- Reviews and provides feedback on clinical operation section of protocols with minimal supervision.
- Understand business value and balance overall business objectives and functional needs.
- Minimum of a Bachelor’s Degree required; preferably in Life Science, Physical Science, Nursing, or Biological Science.
- BS with at least 4 years, MS with at least 3 years, PhD with at least 1 years of relevant experience preferred.
- Knowledge of Good Clinical Practices is required.
- Strong written, oral communication, and presentation skills are required.
- Strong project management skills with ability to handle multiple projects is required.
- Previous experience in clinical trial management or equivalent is required.
- Clinical/medical background is preferred.
- Medical device experience is a plus.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
North America-United States-New Jersey-Somerville
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