Clinical Team Lead - Home-Based in the USA - Oncology
Location: San Diego
Posted on: October 12, 2021
Clinical Team Lead - Home-Based in the US (Country Lead
This position requires experience as a CRA and as a Lead Monitor in
Pharma and/or CRO.
Why settle for one thing when you can have everything?
Drug Development gives you the best two-for-one
opportunity for career growth. Who doesn’t want twice
the perks? Working at one of the largest FSP
CROs—and partnering with one sponsor with a dedicated therapeutic
focus. You can have it all!
to an FSP project, you will
bring your specialized discipline to a core team working directly
with one sponsor. Whether your specialization is in clinical
monitoring, clinical project management, data management,
biometrics or pharmacovigilance, we have an FSP opportunity to match your
area of expertise.
will enjoy the best of both worlds—all the benefits that come along
with our Energizing Purpose, Exceptional People and Extraordinary
Potential combined with working exclusively with one sponsor and
this also comes with the benefit of bringing your strong
therapeutic experience to allow your expertise to shine
FSP model is flexible and scalable. Our teams are collaborative and
proactive – a great place for you to continue honing your
therapeutic skills and growing and excelling in new and exciting
reach is global – extending to 60+ countries making us one of the
largest FSP CROs. No matter where you are located on the globe, we have an FSP
opportunity for you.
Clinical Team Lead
Clinical Team Lead (CTL) is responsible and accountable for the
execution of the clinical operations component of the project, at
the global or regional level, as assigned. The CTL is
responsible for working cross functionally, within a matrix
environment, to ensure successful execution of the trial including
oversight of the clinical operations from a quality, timeline,
budget and scope perspective.
Essential Job Duties:
the cross-functional Country Feasibility team and process,
involving the local Monitoring and Site Management and local
Medical organizations. A reliable operational feasibility
assessment is critical to the overall planning conduct of the
global study. The CTL provides the GMSM country head (LHMSM or
CCRM) with advice on operational feasibility of study design,
timelines, cost, patient enrollment projections, and potential
sites. This process must be consistent with the Study Concept
provided by the GCL and requires significant collaboration on a
local cross functional level.
cross-functional Site Selection Team to identify and determine
interest and suitability of investigator's for participation in the
Core Country Study Documents to initiate the study and ensures all
study sites are initialed according to planned study
the Country Enrollment and Retention Plan. Managing and tracking
country site initiation, enrollment, data cleaning activities to
ensure they are consistent with country commitments and study
timelines. Develops contingency plan to ensure site and country
commitments are met.
and tracking the Study Country Level and site Budget, providing
monthly country budget information to Local Controlling, LHMSM and
Study Manager, as well as identifying budget/estimate issues and
proactively developing a plan for resolving study finance issues.
The CTL manages country budget and payments in appropriate
all country CRAs are trained sufficiently for the trial. Identifies
training gaps if additional training is required at country level
works with the Study Lead Monitor to develop further training
plans. Responsible for training all new CRAs for the
Country Study Oversight Plan to ensure quality and compliance which
may include co-monitoring visits and coordinating Data Verification
identifying potential or actual country related issues. Responsible
for Country Level Corrective Action I Preventive Action Plans
(CAPAs) to ensure timely and sufficient resolution of issues that
may impact the quality and compliance of the data, keeping SLM and
LHMSM well informed of the status of the CAPAs
Country Monthly report and proactively notifying SLM and LHMSM of
any potential issues with proposed solutions to ensure country
participation remains consistent with country
outsourced studies: the CTL is the primary contact with the country
CRO team and will support the CRO with regulatory and ethics
submissions. The CTL will keep the Country Medical Director and
local MSM teams informed of the status of the study. In addition,
the CTL may conduct co-monitoring visits with the CRO as detailed
in the Study Oversight Plan
CTL may be assigned monitoring and site management responsibilities
when required due to study workload.
- Must have a
Bachelor’s Degree (or equivalent) with 6 – 7 years of relevant
healthcare experience including 4 years of monitoring & site
- 2-4 years’
experience as a CTL, or an equivalent combination of education and
experience to successfully perform the key responsibilities of the
•Minimum 4+ years CRA experience, on-site or in-house.
- In lieu of the
above minimum requirement, candidates with 6 or more years of
relevant clinical research experience in pharmaceutical, CRO or
health care setting will be considered.
Keywords: Labcorp, San Diego , Clinical Team Lead - Home-Based in the USA - Oncology, Other , San Diego, California
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