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.
Clinical Trial Leader (CTL) will be responsible for leading one or several
clinical trials within the Clinical R&D Operations COE.
strong, productive relationships with colleagues across the organization
as the trial leader for clinical trial execution
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
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
serve as the primary contact for clinical trial sites
operational activities of assigned clinical studies within the Clinical R&D
problems with support from Clinical Management arising during clinical trial
execution, and will seek guidance for more complex problems, as needed
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
be involved in other tasks to support Clinical R&D Operations and R&D
Clinical Franchise as needed
assigned projects budgets to ensure adherence to business plans
the implementation of new clinical systems/processes, and provide support for
publications, as needed.
and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH,
contractors/vendors, and company personnel
for quality, compliance with regulations and company procedures, timelines, and
budgets for assigned clinical trials
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).
assist with the management of large regulated or complex trials under
supervision of CTM or Senior CTM
and ensure strategies, resources, and accountabilities are in place to achieve
rapid, high quality execution of assigned clinical trials under his/her
of a Bachelor’s/University Degree or equivalent required.
Degree in Life Science, Physical Science, Nursing, or Biological Science is
years of relevant industry experience is required
of Good Clinical Practices is required
experience in clinical trial management/execution or equivalent is required
knowledge of all phases of clinical trial management (e.g. study start up,
interim study management and study closeout) is preferred.
industry certifications preferred (i.e., CCRA, RAC, CDE).
backgrounds a plus.
device experience a plus.
is an equal opportunity employer
United States-Massachusetts-RaynhamOther 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-IrvineOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Trial Administration
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