JOB SUMMARY The Clinical Operations Lead (COL) serves as theclinical functional lead, accountable for the clinical monitoring/sitemanagement delivery of assigned study(ies). The position as defined by scopeprovides leadership, mentoring, and technical support to the ClinicalOperations team to ensure quality of deliverables and achievement of financialgoals. May provide administrative line management, which includes oversight oftraining, compliance, performance and career management, and development ofdirect reports. JOB RESPONSIBILITIES ·Ensures quality of the clinical monitoring and sitemanagement deliverables within a project and maintain proper visibility of itsprogress by the use of approved systems and / or tracking tools.May include the development of the ClinicalManagement Plan (CMP)/Site Management Plan (SMP). ·Interacts with the client and other functional departmentsrelated to clinical monitoring and site management activities and deliverables. ·Ensures alignment of clinical activities to budget, includingidentification of out of scope activities. ·May participates in business development proposals, defensemeetings and proposal development. ·As required, provides development and delivery of initial andongoing training to the study team regarding protocol specificities, CaseReport 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 teamcalls to provide status updates, ongoing training and accountability todeliverables. ·May evaluate staff’s competency to perform visits/sitecontact independently via sign-off visits and Performance Assessment Visits(PAVs) according to company standards and process. ·Adheres to scope and routinely reviews Clinical TrialManagement 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 timelyentry of all operational aspects (required visits/calls, duration, andfrequency) according to plan, and to oversee site and study team conduct andidentify any risks to delivery or quality. ·Reviews the content and quality of site monitoringdocumentation (site monitoring calls, site visit reports, site letters, andpertinent correspondence), to ensure they represent site management activitiesand conduct. Ensures these deliverables are provided according to companyand/or sponsor specifications, including delivery deadlines. ·Understands the monitoring strategy required for the studyand where required participates in the development of the study risk assessmentplan.Is accountable for the clinicalteams understanding, ongoing compliance and delivery according to the statedmonitoring strategy, CMP/SMP, and risk plans. ·Adheres to scope to ensure assigned clinical staff routinelyassess site processes, perform review of all Source Documents and medicalrecords, and perform Source Document Verification (SDV) per the CMP/SMP andreviews identified and newly emerging risks. Develops and executes correctiveaction plans at site and study level, proportionate to the risks identified.Utilizes systems and tools to assess Key Risk Indicators (KRIs) and ensuresthat monitoring visits/calls are occurring in line with CMP/SMP.Proactively collaborates with the datamanagement functional lead to plan towards data cut and lock deadlines. ·Collaborates with other functions to ensure site complianceand delivery according to protocol, ICH/GCP and or Good PharmacoepidemiologyPractices (GPP) and country regulations, including medical monitoring, Safety,Quality Assurance (QA). Ensures Inspection Readiness for Clinical Scope.QualificationsQUALIFICATION 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%