This is a great project management opportunity for an existing CTL, Lead Monitor or Start up Lead

Focus on study set up and quality monitoring delivery oversight - this is a 100% Sponsor dedicated role.

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.

The role is a Country Lead Monitor (CLM)

The CLM provides the senior study leaders with:

• Advice on operational feasibility of study design, timelines, cost, patient enrolment projections, and potential sites.

The CLM leads a cross functional team to deliver:

• Identify and determine interest and suitability of investigator's for participation in the assigned study
• DevelopCore Country Study Documents to initiate the study and ensures all study sites are initiat ed according to planned study timelines.
• Developthe Country Enrolment and Retention Plan.
• Manage and trackcountry 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.
• Manage the Study Country Level and site Budget, providing monthly country budget information

The CLM management of Clinical team:

• 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.
• OverseeCountry Study Oversight Plan to ensure quality and compliance which may include co-monitoring visits and coordinating Data Verification Initiatives.
• 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
• Provide Country Monthly report and proactively notifying leaders of any potential issues with proposed solutions to ensure country participation remains consistent with country commitments.
• The CLM may be assigned monitoring and site management responsibilities when required due to study workload.

For outsourced studies:

• To be primary contact with the country CRO team and support the CRO with regulatory and ethics submissions.
• The CLM will keep the Country Medical Director and local MSM teams informed of the status of the study.
• T he CLM may conduct co-monitoring visits with the CRO as detailed in the Study Oversight Plan

Please contact Andy Smith on 07775 848 250 for further detail and discussion

key words Lead CRA, clinical team leader, project management, senior clinical research associate, CRA, SCRA

Education / Qualifications

Bachelor's Degree (or equivalent)

Experience

6 - 7 years of relevant healthcare experience including 4 years of monitoring & site management experience

Education/Qualifications:
Bachelor's Degree (or equivalent)
Experience:
6 - 7 years of relevant healthcare experience including 4 years of monitoring & site management experience