J&J Family of Companies Sr. Clinical Trial Leader, Medical Device Operations in Raynham, Massachusetts
- 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.\
We are currently recruiting for a Sr. Clinical Trial Leader to be located in Raynham, MA, West Chester, PA, Warsaw, IN OR Leeds, UK.
This individual will be responsible for leading one or several clinical trials as well as encouraging strong, positive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution.
Position duties & responsibilities:
Serve as a Senior Clinical Trials Leader within Clinical Operations group to execute company sponsored 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 mentorship for more complex problems, as needed
Provide internal communication of clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge
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.
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.
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 sophisticated 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 Proficiencies:
Requires understanding of Good Clinical Practices
Understanding and application of regulations and standards applied in clinical areas/regions is required.
Written and oral communication skills.
Leadership required in alignment with J&J Leadership Imperatives:
Connect - develop collaborative relationships with key internal and external partners, principally within allocated study teams and department and wherever possible across the CoE as well as the resources providers and vendors to build a strong and positive relationship.
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 and those of any direct reports are met on time, and 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 integrity, ethics and compliance at all times.
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- 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 proven 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 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.
United States-Massachusetts-Raynham-325 Paramount Drive
United Kingdom-England-Leeds, United States-Indiana-Warsaw, United States-Pennsylvania-West Chester
Medical Device Business Services, Inc (6029)
J&J Family of Companies
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