Senior Clinical Line Manager

🔥 1 minute ago

🌐 Netherlands, Serbia, +4 more countries – Remote

🇳🇱 Netherlands – Remote 🇷🇸 Serbia – Remote 🇸🇪 Sweden – Remote 🇭🇷 Croatia – Remote 🇩🇪 Germany – Remote 🇲🇰 North Macedonia – Remote

⏰ Full Time

🟠 Senior

👔 Manager

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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• Support study teams in resourcing CRAs and other clinical operations staff for planned and ongoing clinical trials • Supervise and assist with clinical monitoring study team assignments and workload • Continuously monitor CRA and clinical operations staff performance, including monitoring plan compliance, trip report turnaround and quality, action item management, query management, data currency, and TMF management • Manage site trends through dashboard review and ongoing risk assessment • Conduct, attend, or support co-monitoring visits and training as needed to evaluate CRAs • Support study team and other projects based on program/company needs • Assist with development of study and program plans, including Monitoring Plans and eCRF Completion Guidelines • Implement individual development and provide coaching and mentoring to monitoring personnel • Lead and author training programs for monitoring operations teams • Propose proactive and innovative solutions to monitoring team challenges • Establish communication with Clinical Leads, Project Managers, and internal and external stakeholders • Manage and escalate CRA clinical delivery issues to Clinical Operations • Ensure monitoring teams comply with GCP, regulatory agency requirements, and ICH guidelines • Lead monitoring of clinical operations milestones and timelines • Compile and report KPIs across site monitoring CRA teams and drive business improvement insights • Perform oversight visits of CRAs • Lead monitoring operations, quality, and process improvement initiatives with Clinical Operations leadership • Manage, mentor, and develop junior staff • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree required, preferably in life sciences, nursing, or a related discipline • Minimum 10 years of experience working in clinical research • Minimum 5 years of experience in a monitoring leadership capacity including direct report management • Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations • Experience working in CTMS, EDC, IVRS, and eTMF systems • Experience managing, mentoring, and developing junior staff • Demonstrated experience in change management initiatives • Excellent verbal and written communication skills • Interpersonal and presentation skills • Extensive understanding of SOPs, Work Instructions, regional and global regulations, ICH Guidelines, and GCPs governing clinical trials • Ability to partner with cross-functional internal and external stakeholders • Ability to prioritize multiple tasks, plan proactively, and accomplish goals using work instructions and procedures • Ability to develop tools and processes that increase measured efficiencies of the project • Ability to anticipate obstacles and proactively develop solutions to achieve project goals • Ability to compile and report individual and team KPIs

🏖️ Benefits

• Hybrid working encouraged for new hires based within a reasonably short commute of an office • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion • Safe and empowering workplace environment • Applications personally reviewed by recruitment team • Applicants receive an outcome on their application

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