Clinical Trial Manager – Project Management

• Provide site management 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 critical data, process and protocol-execution risks and develop mitigations using the RACT
• Review study scope, budget and protocol content and ensure clinical project teams understand contractual obligations
• Identify and escalate risks to timelines, quality, budget and contracted scope
• Participate in and present at key meetings, including Kick Off Meetings
• Serve as an escalation point for investigator site staff communications and interact with investigators and site staff by phone or in person
• Collaborate with Study Start Up, Patient Recruitment, Data Management and other functions to meet study milestones
• Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans
• Ensure CTMS, dashboards and other systems are configured and available, including user acceptance testing and access/audit trail reviews
• Coordinate study-team training on protocols, CRF completion, dashboards, SOPs, clinical plans, data plans and timelines
• Oversee CRA and Central Monitor resourcing, site assignments and study-team conduct
• Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables
• Review oversight dashboards and clinical trial systems 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, compliant delivery
• Provide client, project management and leadership updates on deliverables and risks
• Support inspection readiness, corrective action plans, data cuts and database lock deadlines
• Oversee CRAs and Central Monitors, assess compliance and identify emerging risks
• Provide staff-performance feedback to line managers; may support larger, more complex trials

• 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 the achievement of 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 other applicable regulatory requirements
• Good computer skills
• Good communication, presentation and interpersonal skills among project team and with sites
• Strong conflict resolution skills
• Ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach
• Critical thinking to determine causes and appropriate solutions to issues
• Moderate travel may be required, approximately 20%

• 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 inclusion
• Diversity, equity and belonging initiatives