Senior Clinical Line Manager

About the role

ProPharma, a consulting firm supporting biotech, medical device and pharmaceutical organisations with regulatory, clinical research, quality, pharmacovigilance and R&D services, is looking for a Senior Clinical Line Manager. The role supervises clinical monitoring teams, ensures compliance with GCP and ICH guidelines, and leads monitoring operations and quality improvement.

Key responsibilities

• Support study teams in resourcing CRAs and other clinical operations staff for planned and ongoing trials
• Supervise and assist with clinical monitoring assignments and workload
• Monitor performance of CRAs and operations staff, including clinical monitoring plan compliance, trip report turnaround, quality, action items, queries, data currency and TMF management
• Manage site trends through dashboard review and risk assessment, and oversee CRA visits
• Lead and author training programmes for monitoring teams and coach and mentor monitoring personnel
• Assist with study and programme plans such as Monitoring Plans and eCRF completion guidelines
• Compile and report KPIs across CRA teams and drive improvements
• Lead monitoring operations, quality and process improvement initiatives with Clinical Operations leadership
• Mentor and develop junior staff and propose proactive solutions to monitoring challenges

Required profile

• Bachelor's degree, preferably in life sciences, nursing or a related discipline
• Minimum 10 years of experience in clinical research
• Minimum 5 years in a monitoring leadership capacity with direct report management
• Demonstrated experience in change management initiatives

Required skills

• Extensive knowledge of SOPs, regional and global regulations, ICH guidelines and GCP
• Experience with CTMS, EDC, IVRS and eTMF systems
• Microsoft Office (Word, Excel, PowerPoint)
• Ability to compile and report KPIs and to manage multiple tasks proactively