Clinical Team Manager (US Remote)
Company: ICON Strategic Solutions
Location: Salem
Posted on: January 19, 2023
Job Description:
ICON plc is a world-leading healthcare intelligence and clinical
research organisation. From molecule to medicine, we advance
clinical research providing outsourced services to pharmaceutical,
biotechnology, medical device and government and public health
organisations. With our patients at the centre of all that we do,
we help to accelerate the development of drugs and devices that
save lives and improve quality of life. Our people are our greatest
strength, are at the core of our culture, and the driving force
behind our success. ICON people have a mission to succeed and a
passion that ensures what we do, we do well.What will you be
doing?As a Country Lead Monitor, you are accountable and
responsible for overall country clinical trial activities in
assigned studies. The CLM oversees the CRAs and overall study
progress for assigned studies within his/her country from country
feasibility assessment through to study archive. The CLM manages
the Country Feasibility process, involving local Monitoring and
Site Management (MSM) personnel and local Medical teams. The CLM
leads the country cross-functional Investigator Site Selection
Team; prepares Core Country Study Documents to initiate the trial;
manages Country Study Budget including estimates and payments;
develops the Country Enrollment Plan; tracks country site
initiation; enrollment and data cleaning activities to ensure they
remain in line with country commitments.
- Responsible for ensuring country CRAs are trained appropriately
on all aspects of the study and implementing and overseeing the
Study Oversight Plan in their country which may include
co-monitoring visits or coordinating Data Verification
Initiatives.
- Proactively identifies country related issues and develops the
Country Corrective Action and Preventive Action Plans to ensure
timely and sufficient resolution of country issues that may impact
the compliance or quality of study data or activities.
- Responsible Country Monthly Report and proactively notifies the
Local Head of Monitoring and Site Management, Manager of MSM,
Manager of Country Clinical Trial Management and Study Lead Monitor
(SLM) of any potential quality, safety or commitment issues with
proposed solutions to ensure country involvement in the study
remains consistent with country commitments with regards to all
country timelines, enrollment and country study budget.
- All of the above are relevant for internally monitored
studies.
- For outsourced studies, a CLM will be assigned to ensure that
relevant information regarding the Clinical Research Organizations
(CROs) country-related activities are cascaded through the country
organization as appropriate.
- Support the CRO with regulatory and country initiation
activities. The CLM or a Sr. CRA may conduct co-monitoring visits
with the CRO, if required, as detailed in the Study Oversight
Plan.
- Due to the increased scrutiny of regulatory authorities on the
quality of clinical trial data, and increased business demands to
conduct clinical trials in an efficient manner, the focus of the
CLM position is strengthened to reflect greater focus on quality
and oversight and achieving commitments.
- To ensure consistency, quality and efficiency across the
Country CRA Study Team, a CLM is assigned for every participating
country and is responsible for and oversees the CRAs and study
progress at the country level from study feasibility to study
archive.
- Requires significant country cross functional collaboration
throughout the study conduct.
- Manage 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 CLM provides the GMSM country head (LHMSM) 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
- Lead cross-functional Site Selection Team to identify and
determine interest and suitability of investigators for
participation in the assigned study.
- Develop Core Country Study Documents to initiate the study and
ensures all study sites are initiated according to planned study
timelines.
- Develop 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.
- Manage and tracking the Study Country Level 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 CLM manages country budget and payments in appropriate
tools.
- Ensure 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
study.
- Oversee Country Study Oversight Plan to ensure quality and
compliance which may include co-monitoring visits and coordinating
Data Verification Initiatives.
- Oversee Investigator site activities to ensure delivery of
country commitments and to make certain the operational study
execution is on track from site selection to site close out.
- Ensure completion of site documents necessary for ethics and
regulatory approval for site initiation within agreed upon
timelines. Ensuring all legal, regulatory and Sponsor requirements
are met prior to drug shipment to sites as well as all site
initiation processes are completed.
- Oversee country-level study activities to ensure ethical and
regulatory compliance necessary to provide quality data required
for global regulatory submissions for approval of drugs.
- Ensure applicable authorities are notified of study closure and
final patient status in accordance with ICH and local
regulations.
- Proactively identify potential or actual country related
issues. Responsible for Country Level Corrective Action /
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
- Create Country Monthly report and proactively notifying SLM,
CCTM and LHMSM of any potential issues with proposed solutions to
ensure country participation remains consistent with country
commitments.
- For outsourced studies: the CLM is the primary contact with the
country CRO team and will support the CRO with regulatory and
ethics submissions. The CLM will keep the Country Medical Director
and local MSM teams informed of the status of the study. In
addition, the CLM may conduct co-monitoring visits with the CRO as
detailed in the Study Oversight Plan
- The CLM does not have direct reports but is responsible for
overseeing the CRA activities at the country level for the assigned
studies. Key work relations are with Study Lead Monitors (SLM),
other CLMs, country CRAs, Study Data Manager, Study Medical Experts
and country Medical Advisors.What do you need?Education required:
Bachelors degree in a health, life sciences or other relevant field
of studyExperience required: 5 years relevant experienceBenefits of
Working in ICON:Our success depends on the knowledge, capabilities
and quality of our people. Thats why we are committed to developing
our employees in a continuous learning culture one where we
challenge you with engaging work and where every experience adds to
your professional development.At ICON, our focus is to provide you
with a comprehensive and competitive total reward package that
comprises, not only an excellent level of base pay, but also a wide
range of variable pay and recognition programs. In addition, our
best in class employee benefits, supportive policies and wellbeing
initiatives are tailored to support you and your family at all
stages of your career - both now, and into the future.ICON,
including subsidiaries, is an equal opportunity and inclusive
employer and is committed to providing a workplace free of
discrimination and harassment. All qualified applicants will
receive equal consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.If, because of a
medical condition or disability, you need a reasonable
accommodation for any part of the application process, or in order
to perform the essential functions of a position, please let us
know.
Keywords: ICON Strategic Solutions, Salem , Clinical Team Manager (US Remote), Healthcare , Salem, Oregon
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