Clinical Trial Manager – Single Sponsor

• Manage site oversight, clinical monitoring, and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance, and data integrity
• Oversee site interactions from activation through closeout, including recruitment, investigator payments, and related activities
• Identify clinical trial risks and implement risk mitigations
• Review study scope, budget, protocol content, and contractual obligations with the clinical project team
• Escalate timeline, quality, budget, and out-of-scope risks to the project manager
• Participate in and present at key meetings, including Kick Off Meetings
• Serve as an escalation point for investigator site communications and interact with principal investigators and site staff
• Coordinate delivery handoffs with Study Start Up, Patient Recruitment, and Data Management teams
• Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans
• Ensure CTMS, dashboards, and other systems are configured and available, including overseeing UAT and audit trail reviews
• Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, data, and timelines
• Oversee CRA and Central Monitor resourcing, site assignments, conduct, and delivery risks
• Monitor quality and progress of clinical monitoring, central monitoring, and site management deliverables
• Review clinical trial systems and dashboards, including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards
• Oversee compliance with monitoring strategies, CMP/SMP, and risk plans
• Review site and central monitoring documentation and ensure timely revisions, approvals, and delivery
• Provide client, project-management, and leadership status updates on deliverables and risks
• Support inspection readiness, corrective action plans, data cuts, and database lock deadlines
• Oversee CRAs and Central Monitors and provide performance feedback to line managers

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
• Demonstrated ability to lead and align teams in achieving project milestones
• Demonstrated capability of working in an international environment
• Demonstrated expertise in site management and monitoring (clinical or central)
• Preferred experience with risk-based monitoring
• Understanding of clinical trial management financial principles and budget management
• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
• Good computer skills
• Good communication, presentation and interpersonal skills
• Strong conflict resolution skills
• Fluency in both German and English
• Ability to apply problem-solving techniques to resolve complex issues and use a risk-management approach
• Critical-thinking ability to identify issues and determine appropriate solutions
• Approximately 20% travel may be required

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Total Self culture supporting authenticity and belonging
• Diversity, inclusion and belonging initiatives