Clinical Trial Leader
Location:
West Chester , Pennsylvania
Posted:
February 08, 2017
Reference:
9349161031/2-en-us

The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Clinical Trial Leader (CTL) located in Westchester, PA, Raynham, MA, Irvine CA, Cincinnati OH, OR Warsaw IN.


The MD CR&D COE is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Device companies.  The COE organization is based on three functional teams: Franchise, Operations and Biostatistics & Data Management.  All three teams share accountability for the successful development and delivery of clinical evidence globally to internal and external (5Ps) stakeholders that drives innovation in surgical solutions and that optimizes the product lifecycle.  Each team within CR&D COE will have primary responsibility for defined areas of clinical program development, execution and dissemination.

  • The Clinical Trial Leader (CTL) will be responsible for leading one or several clinical trials within the Clinical R&D Operations COE.
  • Fostering strong, productive relationships with colleagues across the organization
  • Serves as the trial leader for clinical trial execution 
  • 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
  • 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.
 
 


Qualifications
  • Minimum of a Bachelor’s/University Degree or equivalent required.
  • A Degree in Life Science, Physical Science, Nursing, or Biological Science is preferred
  • 2 years of relevant industry experience is required
  • Understanding of Good Clinical Practices is required
  • Previous experience in clinical trial management/execution or equivalent is required
  • Demonstrable knowledge of all phases of clinical trial management (e.g. study start up, interim study management and study closeout) is preferred. 
  • Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
  • Clinical/medical backgrounds a plus.
  • Medical device experience a plus.
  • Travel: 10-15% domestically
 #HEMAONCO

 


J&J is an equal opportunity employer

 
 


Primary Location
United States-Massachusetts-Raynham
Other Locations
North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-California-Irvine
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Clinical Trial Administration

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