The Senior Clinical Operations Lead (COL) serves as
the clinical functional lead, accountable for the clinical monitoring/site
management delivery of assigned tasks and project(s) as per scope.. The Senior
COL may provide oversight and coordination of COL(s) working across regions
and/or countries to ensure clinical project and site deliverables are met. The
position provides leadership, mentoring, and technical support to the Clinical
Operations team to ensure quality deliverables and achievement of milestones
and financial goals. May provide administrative line management, which includes
oversight of training, compliance, performance, development and career
management of direct reports.
·Ensure quality of the clinical monitoring and site management
deliverables within a project and/or program and maintain proper visibility of
its progress by the use approved systems and / or tracking tools.May include the development of the Clinical
Management Plan (CMP)/Site Management Plan (SMP).
·Interact with the client and other functional departments related
to clinical monitoring and site management activities and deliverables.
·May participate in business development activities including
project clinical operations/site management strategy and budget input, defense
meetings and proposal development.
·As required, provides development and delivery of initial and
ongoing training to the study team regarding protocol specifics, Case Report
Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical
plans and guidelines, data plans and timelines for the project.Plans and leads regular clinical project
team calls to provide status updates, ongoing training and accountability to
·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.
·Coaches and mentors COLs regarding functional clinical delivery,
evaluation of project risks, and action implementation.Also sets priorities for the COL team to
complete and manage on a regional and site level.
·Globally reviews Clinical Trial Management System (CTMS), Case
Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Strategic Data
Monitoring (SDM) and/or other dashboards to oversee site and project team
conduct, ensures timely entry of all operational aspects (required visits,
duration, and frequency) according to plan, andidentifiesrisks to delivery or
·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
·Understands the monitoring strategy required for the project and,
where required, participates in the development of the project 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
·Collaborates with other functional areas 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.
·As defined by scope may be responsible for team member
clinical/site management project deliverables as the clinical functional team
leader.Drives and manages the clinical
and site management aspects of assigned project.May be a standalone lead or part of a
regional or global clinical functional lead team.Reviews the study scope of work, budget and
protocol content and ensures the clinical project team (CRAs/CMAs/SMAs) is
aware of the parameters.Escalates to
the PM any clinical/site management deliverables (timeline, quality, and
budget) at risk, and any activities and requests which are out of contracted
scope. Ensure alignment of clinical activities to budget, including
identification of out of scope activities.
·As defined by scope may oversee the global project process and
status of monitoring and data flow. Reviews status and trends at the study
level, holds COL team accountable to manage at site and regional level for
effective and timely Source Document Verification (SDV) and data flow, reviewing
status of site and project eCRF entry, SDV, triggered monitoring conduct, query
response, and data cleanliness.
Proactively collaborates with data management functional lead to plan
towards data cut and lock deadlines.
Develops and executes corrective action plans at study (global) level to
address any issues.
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Prior line management experience preferred
Demonstrated ability to lead and align teams in the achievement of project milestones, as well as demonstrated capability of working in a global 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 and be able to embrace new technologies
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%
Tasks, duties, and responsibilities as listed in this job
description are not exhaustive. The Company, at its sole discretion and with no
prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so
qualifications of incumbents may differ from those listed in the Job
Description. The Company, at its sole discretion, will determine what
constitutes as equivalent to the qualifications described above. Further,
nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief
terms. Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it operates,
including the implementation of the EU Equality Directive, in relation to the
recruitment and employment of its employees.
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