The 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.

#LI-MT1Bachelor'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%