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Clinical Trial Leader
Leeds, United Kingdom
Clinical Trial Administration
Requisition ID: 1805621039W
Job Title: Clinical Trial Leader
Business: DePuy Leeds
Function: Medical Devices
Johnson & Johnson Medical Companies produce a broad range of innovative products and solutions used primarily by health care professionals in the fields of orthopaedics, surgical oncology, general surgery, neurosurgery & neurological disease, infection prevention, cardiovascular disease, and aesthetics. As the most comprehensive devices business in the world, Johnson & Johnson Medical Devices is best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands.
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 trial execution.
POSITION DUTIES & RESPONSIBILITIES:
• 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
• 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
• Manage operational activities of assigned clinical studies within the Clinical R&D Operations group
• Solves 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
• 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
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:
• Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
• May 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).
• May assist with the management of large regulated or complex trials 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.
Functional and Technical Competencies:
• Requires understanding of Good Clinical Practices
• Understanding and application of regulations and standards applied in clinical areas/regions is required
• Presentation skills and influencing of others
• Written and oral communication skills
• Demonstrated competencies in the following areas are required:
• Behaving in a professional and ethical manner
• Technical writing skills
Leadership required in alignment with J&J Leadership Imperatives:
• Connect - Develop collaborative relationships with key internal and external stakeholders, principally within allocated study teams and department as well as the resources providers and vendors to create a strong and productive partnership
• Shape - Actively participate in departmental process improvement activities.
• Lead - Take ownership for development of self and engage in transparent and constructive conversations.
• Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.
• 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.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Performs other related duties as required.
EDUCATION & EXPERIENCE REQUIREMENTS:
• Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science.
• Previous experience in clinical trial management or equivalent is desired.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background a plus.
• Medical device experience a plus.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Johnson & Johnson Medical Ltd. - fka -Ethicon Ltd. (7355)
Clinical Trial Administration