Clinical Research Manager

• Act as line manager for trial monitoring staff (CRAs) in Belgium
• Plan, assign, and direct work; assess performance and guide professional development of direct reports
• Participate in hiring selection and allocate resources to clinical research projects
• Assign staff to clinical studies based on experience and training
• Ensure clinical trial protocols are executed according to ICH/GCP, local regulations, and applicable SOPs
• Collaborate with the Regional Clinical Operations Manager to maintain study timelines and quality standards
• Support study start-up and provide local expertise
• Manage study start-up and trial monitoring staff in accordance with company policies and regulations
• Ensure onboarding and training of new employees and oversee training plans
• Manage quality of assigned staff's clinical work through regular review and evaluation
• Provide country-specific study start-up expertise and review study documents, drug labels, ICFs, and templates
• Develop and review site-specific recruitment materials and tools
• Collaborate with study teams and clinical sites on IRB/EC submissions, TMF completeness, site activation, enrollment, and inspection readiness
• Contribute to feasibility, site identification, selection, and evaluation
• Perform accompanied CRA visits and assess performance
• Review visit reports, follow up on issue resolution, and communicate significant risks and proposed actions
• Monitor workload and quality metrics through regular review and reporting
• Anticipate and identify site issues, propose CAPAs, identify gaps, and leverage opportunities
• Promote operating excellence and innovation
• Contribute to Clinical Operations strategy and performance against key metrics
• Mentor and manage junior staff and Clinical Research Associates
• Act as escalation point for CRA site-related issues
• Conduct mid-year and year-end performance appraisals for direct reports

• Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline
• Minimum 5-7 years progressive experience in clinical operations within the biotech/pharmaceutical sector
• Prior clinical trial experience including experience in a management/leadership capacity
• Experience in oncology is highly recommended
• Ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Minimum 5-7 years progressive experience in clinical operations, preferably including at least 2 years of line management in the pharmaceutical or CRO industry
• Excellent interpersonal skills and strong organizational skills
• Fluent in German & the country language (writing and speaking)
• Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
• Willingness to travel up to 30-40%