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.
• 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.
QUALIFICATION REQUIREMENTS (please indicate if 'preferred')
• 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%
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.