Clinical Team Lead - South of England (Client Dedicated)

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 10pt; font-family: Arial, sans-serif;">This is a great project management opportunity for an existing CTL, Lead Monitor or  Start up Lead</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Focus on study set up and quality monitoring delivery oversight - this is a 100% Sponsor dedicated role.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">You would be employed permanently by Labcorp and outsourced to a global pharma company - home based in the UK. We will consider candidates anywhere in the UK.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">The role is a Country Lead Monitor (CLM)</span></strong></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">The CLM provides the senior study leaders with:</span></p><ul style="margin-top: 0cm;"><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Advice on operational feasibility of study design, timelines, cost, patient enrolment projections, and potential sites.</span></li></ul><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: Arial, sans-serif;">The CLM leads a cross functional team to deliver:</span></p><ul style="margin-top: 0cm;"><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Identify and determine interest and suitability of investigator's for participation in the assigned study</span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Develop Core Country Study Documents to initiate the study and ensures all study sites are initiat</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">ed according to planned study timelines.</span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Develop the Country Enrolment and Retention Plan. </span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;"><span style="color: #333333;">Manage</span></span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;"> and track country site initiation, enrolment, data cleaning activities to ensure they are consistent with country commitments and study timelines. Develops contingency plan to ensure site and country commitments are met.</span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Manage the Study Country Level and site Budget, providing monthly country budget information </span></li></ul><p style="margin: 0px;"><span style="font-size: 10pt; font-family: Arial, sans-serif;">The CLM management of Clinical team:</span></p><ul style="margin-top: 0cm;"><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Ensuring all country CRAs are trained sufficiently for the trial. Identifies training gaps if additional training is required at country level and works with the Study Lead Monitor to develop further training plans. Responsible for training all new CRAs for the study.</span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Oversee Country Study Oversight Plan to ensure quality and compliance which may include co-monitoring visits and coordinating Data Verification Initiatives.</span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Proactively identifying potential or actual country related issues. Responsible for Country Level Corrective Action I Preventive Action Plans (CAPAs) to ensure timely and sufficient resolution of issues that may impact the quality and compliance of the data</span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10pt; font-family: Arial, sans-serif;">Provide</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;"> Country Monthly report and proactively notifying leaders of any potential issues with proposed solutions to ensure country participation remains consistent with country commitments.</span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">The CLM may be assigned monitoring and site management responsibilities when required due to study workload.</span></li></ul><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Noto Sans'; color: #333333;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: Arial, sans-serif;">For outsourced studies: </span></p><ul style="margin-top: 0cm;"><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10pt; font-family: Arial, sans-serif;">To be </span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">primary contact with the country CRO team and support the CRO with regulatory and ethics submissions. </span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">The CLM will keep the Country Medical Director and local MSM teams informed of the status of the study. </span></li><li style="color: #333333; margin-left: 0cm;"><span style="font-size: 10pt; font-family: Arial, sans-serif;">T</span><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">he CLM may conduct co-monitoring visits with the CRO as detailed in the Study Oversight Plan</span></li></ul><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Noto Sans'; color: #333333;"> </span></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Noto Sans'; color: #333333;"> </span></p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">Please contact Andy Smith on 07775 848 250 for further detail and discussion</span></strong></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Noto Sans'; color: #333333;"> </span></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">key words Lead CRA, clinical team leader, project management, senior clinical research associate, CRA, SCRA</span></p><p style="margin: 13.5pt 0cm 6.75pt 0cm;"><span style="font-size: 13.5pt; font-family: inherit; color: #333333;">Education / Qualifications </span></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">Bachelor’s Degree (or equivalent)</span></p><p style="margin: 13.5pt 0cm 6.75pt 0cm;"><span style="font-size: 13.5pt; font-family: inherit; color: #333333;">Experience </span></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: #333333;">6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-size: 10pt; font-family: Arial, sans-serif;">Bachelor’s Degree (or equivalent)</span></p><h2>Experience:</h2><p style="margin: 0px;"><span style="font-size: 10pt; font-family: Arial, sans-serif;"> 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience</span></p>