Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS)
Group within Medical Devices is recruiting for a Senior Clinical Trial Leader
(Senior Clinical Research Associate) for Biosense Webster to be located in Irvine, CA Mar-Apr of this year. Until that time individuals can be based either in Diamond Bar CA or Irvine CA understanding that it will ultimately be based in Irvine CA...
The CSS Group serves a diverse base of customers in Ear, Nose and
Throat (ENT), Infection Prevention, Electrophysiology, Surgical and
Non-Surgical Aesthetics, Sedation and Reprocessing all headquartered in our
talent hub in Irvine, CA.
The Senior Clinical Trial Leader will or may be responsible for:
- Clinical study execution within the
Cardiovascular & Specialty Solutions group and the overall Clinical Center
- Fostering strong, productive relationships with
colleagues within the organization.
- Serving as a member of the study core team and
may serve as the liaison with the operating company for projects under his/her
- Overall execution of small-medium regulated and
non-regulated clinical projects or large non-regulated clinical projects
including, but not limited to, study planning, initiation, budget tracking,
tracking and supporting subject recruitment, quality of deliverables, site
support and study closure.
- Providing support to department wide training.
- Ensuring that all Human Resource related
activities and decisions embody the Johnson & Johnson Credo Values.
- Quality, compliance with regulations and company
procedures, timelines, and budgets for assigned clinical projects.
- Leading several small/medium clinical studies
(regulated and non-regulated) and/or a small number of large non-regulated
projects that may involve Clinical Research Associates (CRAs) and/or other
clinical operations staff.
- Assisting with the management of large regulated
studies under supervision of CPM or Senior CPM and May support CPM and/or
Senior CPM within a large or complex clinical study.
- Identifying and ensuring strategies, resources,
and accountabilities are in place to achieve rapid, high quality execution of
assigned clinical studies under his/her responsibilities.
- Managing all activities of assigned clinical
studies within the Clinical R&D Operations group.
- Functioning as a reliable, trusted resource of
accurate, up-to-date project knowledge as requested by key stakeholders.
- Evaluating support requests for publications and
to provide consolidated comments and support to the requests.
- Managing Resources assigned to designated
clinical studies to provide quality deliverables while maintaining optimal
- Tracking assigned projects budgets to ensure
adherence to business plans.
- Supporting the implementation of new clinical
systems/processes, and provide support for publications, as needed.
- Interfacing and collaborating with
investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and
- Ensuring personal and company compliance with
all Federal, State, local and company regulations, policies and procedures for
Health, Safety, and Environmental compliance.
- Providing quality feedback to the Directors and
Managers on each resource assigned to clinical studies regarding performance
within the context of the clinical studies.
- A minimum of a Bachelor’s Degree with at least 4
years of clinical or related technical experience required
- A Life
Science, Physical Science, Nursing, or Biological Science degree is preferred
- The ability to influence others along with
strong written and oral communication skills is required
- Knowledge of Good Clinical Practices is required
- Understanding and application of regulations and
standards applied in clinical areas is required
- Project management skills with the ability to
handle multiple projects is required
- Leadership skills in a professional ethical
manner are required
- Technical writing skills are required
- Experience with clinical trial monitoring with
the ability to oversee monitoring activities is preferred
- Experience within a Medical Device,
Pharmaceutical or Contract Research Organization is required
- Experience within the cardiovascular industry is
- Relevant industry certifications are preferred
(i.e., CCRA, RAC, CDE)
- This position may require up to 30% travel
United States-California-Diamond BarOrganization
Biosense Webster Inc. (6010)Job Function
Clinical Trial AdministrationRequisition ID