Clinical Team Lead - Home-Based in the USA - Oncology
Posted on: June 12, 2021
Clinical Team Lead - Home-Based in the US
This position requires experience as a CRA and/or as a Lead
Monitor in Pharma and/or CRO.
Why settle for one thing when you can have everything?
Covance by labcorp 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!
Dedicated 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
You 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
Our 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
Our 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
The 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:
- Managing 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.
- Leading cross-functional Site Selection Team to identify and
determine interest and suitability of investigator's for
participation in the assigned study.
- Developing Core Country Study Documents to initiate the study
and ensures all study sites are initialed according to planned
- Developing 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.
- Managing 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
- Ensuring 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
- Overseeing Country Study Oversight Plan to ensure quality and
compliance which may include co-monitoring visits and coordinating
Data Verification Initiatives.
- Proactively 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
- Creating Country Monthly report and proactively notifying SLM
and LHMSM of any potential issues with proposed solutions to ensure
country participation remains consistent with country
- For 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
- The CTL may be assigned monitoring and site management
responsibilities when required due to study workload.
# LI - Remote
- Must have a Bachelor's Degree (or equivalent) with 6 - 7 years
of relevant healthcare experience including 4 years of monitoring &
site management experience
- 2-4 years' experience as a CTL, or an equivalent combination of
education and experience to successfully perform the key
responsibilities of the job.
- 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: Ockham, Raleigh , Clinical Team Lead - Home-Based in the USA - Oncology, Other , Raleigh, North Carolina
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