Clinical Operations Lead
Company: Aerotek
Location: Morrisville
Posted on: February 21, 2021
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Job Description:
Description:JOB SUMMARYThe Clinical Operations Lead (COL) serves
as the clinical functional lead, accountable for the clinical
monitoring/site management delivery of assigned study(ies). The
position as defined by scope provides leadership, mentoring, and
technical support to the Clinical Operations team to ensure quality
of deliverables and achievement of financial goals. May provide
administrative line management, which includes oversight of
training, compliance, performance and career management, and
development of direct reports.JOB RESPONSIBILITIES Ensures quality
of the clinical monitoring and site management deliverables within
a project and maintain proper visibility of its progress by the use
of approved systems and / or tracking tools. May include the
development of the Clinical Management Plan (CMP)/Site Management
Plan (SMP). Interacts with the client and other functional
departments related to clinical monitoring and site management
activities and deliverables. Ensures alignment of clinical
activities to budget, including identification of out of scope
activities. May participates in business development proposals,
defense meetings and proposal development. As required, provides
development and delivery of initial and ongoing training to the
study team regarding protocol specificities, Case Report Form (CRF)
completion, Sponsor Standard Operating Procedures (SOPs), clinical
plans and guidelines, data plans and timelines for the study. Plans
and leads regular clinical study team calls to provide status
updates, ongoing training and accountability to deliverables. May
evaluate staff's competency to perform visits/site contact
independently via sign-off visits and Performance Assessment Visits
(PAVs) according to company standards and process. Adheres to scope
and routinely reviews Clinical Trial Management System (CTMS), Case
Report Form (CRF), drug management, safety, Trial Master File
(TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where
available) to oversee site and study team conduct, to ensure timely
entry of all operational aspects (required visits/calls, duration,
and frequency) according to plan, and to oversee site and study
team conduct and identify any risks to delivery or quality. Reviews
the content and quality of site monitoring documentation (site
monitoring calls, site visit reports, site letters, and pertinent
correspondence), to ensure they represent site management
activities and conduct. Ensures these deliverables are provided
according to company and/or sponsor specifications, including
delivery deadlines. Understands the monitoring strategy required
for the study and where required participates in the development of
the study risk assessment plan. Is accountable for the clinical
teams understanding, ongoing compliance and delivery according to
the stated monitoring strategy, CMP/SMP, and risk plans. Adheres to
scope to ensure assigned clinical staff routinely assess site
processes, perform review of all Source Documents and medical
records, and perform Source Document Verification (SDV) per the
CMP/SMP and reviews identified and newly emerging risks. Develops
and executes corrective action plans at site and study level,
proportionate to the risks identified. Utilizes systems and tools
to assess Key Risk Indicators (KRIs) and ensures that monitoring
visits/calls are occurring in line with CMP/SMP. Proactively
collaborates with the data management functional lead to plan
towards data cut and lock deadlines. Collaborates with other
functions to ensure site compliance and delivery according to
protocol, ICH/GCP and or Good Pharmacoepidemiology Practices (GPP)
and country regulations, including medical monitoring, Safety,
Quality Assurance (QA). Ensures Inspection Readiness for Clinical
Scope.Skills:Clinical operation, clinical monitoring, clinical
management, CroTop Skills NEEDED: Clinical Monitoring PlanTrip
Report ReviewPerformance Assessment VisitsAdditional Skills &
Qualifications:Bachelor's degree or RN in a related field or
equivalent combination of education, training and experience
Demonstrated ability to lead and align teams in the achievement of
project milestones, demonstrated capability of working in an
international environment. Knowledge of basic clinical project
financial principles Knowledge of Good Clinical Practice/ICH
Guidelines and other applicable regulatory requirements Must
demonstrate good computer skills Excellent communication,
presentation and interpersonal skills. Ability to apply problem
solving techniques to resolve complex issues, and apply a risk
management approach to identifying and mitigating potential threats
to the successful conduct of a clinical research project.
Demonstrates critical thinking to determine the cause and
appropriate solution in the identification of issues Moderate
travel may be required, approximately 20%Experience Level:
Keywords: Aerotek, Cary , Clinical Operations Lead, Other , Morrisville, North Carolina
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