Clinical Team Leader

Clinical Team Leader #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # 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 CMPSite 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 visitssite contact independently via signoff 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, IVRSIWRS enrollment, Data Visualization dashboards where available to oversee site and study team conduct, to ensure timely entry of all operational aspects required visitscalls, 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 andor sponsor specifications, including delivery deadlines.Responsible for study initiation to close out, on timely reporting on all the project status report to the project manager.Responsible for preparing project status report and ensuring all the reports are meeting the time lines.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, CMPSMP, 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 CMPSMP 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 visitscalls are occurring in line with CMPSMP. 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, ICHGCP and or Good Pharmacoepidemiology Practices GPP and country regulations, including medical monitoring, Safety, Quality Assurance QA. Ensures Inspection Readiness for Clinical Scope.A minimum of Graduation Postgraduate in life science Pharmacy Science ManagementManagement with around 810 years of relevant experience in Project Management.Knowledge of clinical research, data management, medical writing and regulatory requirements, Good Clinical Practices