Clinical Affairs Manager
Our client, a medical device organisation, are currently recruiting for Clinical Affairs Manager to join their team on a permanent basis. As Clinical Affairs Manager you will, lead and participate in clinical project teams as part of the company’s clinical programs. The clinical programs include first in human, pilot, pivotal and post-launch studies. You will manage multiple operational studies, provide oversight throughout the development, implementation and conduct of clinical studies globally, develop study plans and project deliverables. You will also be responsible for other non-trial related activities relating to clinical processes and procedures. This is a very exciting opportunity to join a fast growing and dynamic organisation with an extensive research, development and clinical programs planned.


Responsibilities

• Be an effective liaison to build relationships between the organisation and global key opinion leaders and professional societies
• Initiate, develop and manage strong relationships with physicians/investigators, other applicable medical professionals including Contract Research Organizations (CRO’s), and other clinical research service providers to manage clinical trials/registries from initiation through completion
• Develop clinical research documentation including preparation of Clinical documentation and SOPs in accordance with GCP/ICH guidelines
• Manage clinical data collection, trial monitoring and auditing according to GCP guidelines and Standard Operating Procedures. Review site monitoring visits/reports
• Ensure that all Study Personnel have valid certifications/documents (i.e., Citi certifications)
• Ensure clinical studies are carried out in compliance with study protocol, SOPs, and ICH/GCP regulations and procedures
• Provide training to CRO partner resources such as insourcing CRAs, and internal team members including fixed term contractors
• Coordinate and supervise the clinical research support team, supporting clinical cases on site as required
• Manage and ensure that all aspects of clinical trial delivery, including monitoring, data collection and documentation, and site communications are completed professionally, and to the highest standard
• 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 stays up to date with protocol amendments and informs/trains staff when modifications are required
• Set up and work closely with clinical trial physician committees e.g., Clinical Event Committee, Data Safety and Monitoring Board, and Steering Committee
• Participate in internal and external audits, including preparing and supporting clinical sites and staff for audits / inspections
• Communicate clinical study status and highlights issues to all organizational levels including management
• Provide executive summaries on project status as required. Ensure that the Management Team maintain a clear understanding of the status of projects

• The minimum educational qualification is a bachelor’s degree and at least 7 years of clinical research experience
• Minimum 5 years of direct leadership/management experience or comparable experience with a demonstrated ability to attract, coach, lead, motivate and maintain the clinical team
• Knowledge and experience of global regulations and standards affecting 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
• Proven team player with a demonstrated ability to lead and collaborate with cross-functional teams to support project deliverables
• Must be able to travel domestically and internationally by air and car (estimated 30% travel) and work occasional weekends. Must possess a valid driver’s license and passport