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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Training and Compliance Manager


Reference:SCAECN-637241 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Training and Compliance Manager
Our client, a global diagnostics organisation are currently recruiting for a Clinical Training and Compliance Manager to join their team on a permanent basis. As Clinical Training and Compliance Manager you will be responsible for overseeing and execution of operational quality activities within the Clinical Affairs team. You will also work cross functionally with headquarters clinical quality operations and support CTMS migration and set up, to ensure adequate vendor oversight and address any quality issues as needed with cross divisional Clinical teams. As Clinical Training and Compliance Manager you will be responsible for the development of training plans to implement `quality by design` within clinical Affairs team and be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Responsibilities
• Conduct training, directing, developing, and evaluating of clinical research, including writing of SOP’s in accordance with GCP/ICH guidelines
• Coordinate and supervise clinical research support team. Provide project-specific training when applicable
• Provide training to CRO partner resources such as insourcing CRAs, and Internal Clinical team members including fixed term contractors
• Review site monitoring visits/reports
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures
• Ensure all Study Personnel are up to date with all required certifications/documents
• Track and report the progress of studies, including patient enrollment, accounts receivable, monitoring visits, and AE/deviation reporting
• Ensure that supplies and equipment are available for studies as necessary
• Identify and provide solutions to clinical trial issues and/or risks
• Submit IRB applications, and stay up to date with protocol amendments and informs/trains staff when modifications are required/Works closely with sponsors, CROs and CRAs as necessary
• Lead, manage, coach, and mentor the team, including recruitment, onboarding, goal setting, training and development
• Ensure the execution of training plans, SOP review, and understanding and adherence to SOP training matrix
• Ensure quality deliverables, including identifying quality risks, and developing corrective action plans to prevent and/or correct deficiencies
• Collaborate with cross-functional members to support teamwork and project deliverables
• Maintain current knowledge of therapeutic areas, SOP’s and ICH-GCP guidelines
• Ensuring all aspects of trial delivery at the site management level, including monitoring, data collection and documentation, and site communications are conducted professionally and to the highest standard
• Liaise and lead new system implementation eg. CTMS
• Collaborate with wider cross- functional team members to build QMS and support legal Manufacture set up
• Set quality and compliance goals for the trial and monitors/manages compliance
• Lead department-wide efforts to improve and refine existing tools to enhance trial management and communication
• Communicate status and issues to all organisational levels including management
• Solve complex problems within area of responsibility that require ingenuity and creativity
• Demonstrates multi-faceted approach to problem resolution
• Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
• Provide executive summaries on project status as required. Ensure that senior staff maintain a clear understanding of the status of projects
• Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management

Requirements
• The minimum education is a B.Sc. in Life Sciences (or equivalent vocational qualifications e.eg. nursing). An advanced degree is desirable
• Knowledge and experience of global regulations and standards affecting IVDs and Medical Devices. Must have clinical trial management or QA / QM experience preferably within medical devices
• Excellent knowledge of ISO and local regulations required for clinical trials
• Proven record of compliance with, and enforcement of, regulations in clinical trials


For more information please contact Sinéad Cullen on +353879500821 or [email protected]