Single Sponsor Global Clinical Trial Manager II
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Overview
In this role you will oversee site management, clinical and central monitoring to safeguard patient safety, data integrity, and regulatory compliance. You will manage activities from activation to closeout, coordinate with cross-functional teams, and apply risk-based approaches to keep trials on track. You will engage with investigators and sites, support study budgets and timelines, and contribute to inspection readiness. This position offers remote work in the UK, Poland, Spain, or Bulgaria within a large, mission-driven organization.
Compensaciones / Beneficios
- career development and progression
- inclusive culture
- supportive line management
- technical and therapeutic area training
- peer recognition
- total rewards program
- Oversee site management, monitoring and central monitoring deliverables with focus on patient safety and data integrity
- Manage site interactions from activation through closeout, including recruitment and investigator payments as needed
- Identify risks to delivery using operational data and escalate to project manager when necessary
- Collaborate with Study Start Up, Patient Recruitment and Data Management to hit milestones (activation, enrollment, database lock)
- Develop and maintain clinical study tools (e.g., Clinical Monitoring Plan) and ensure CTMS and dashboards are usable
- Coordinate training for study team on protocols, CRF completion, SOPs, data plans and timelines
- Oversee resource allocations for CRAs and Central Monitors, monitor team conduct and risk to delivery
- Review and provide feedback on functional plans and ensure quality of monitoring and site management deliverables
- Interact with clients and cross-functional departments to report status and resolve protocol execution obstacles
- Support inspection readiness and develop corrective action plans as needed
- Provide performance feedback to line managers and 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 to milestones
- Experience in international environments and in site management/monitoring
- Knowledge of GCP/ICH guidelines and regulatory requirements
- Strong communication, presentation and interpersonal skills
- Good computer skills and familiarity with trial systems
- Ability to apply risk management and problem solving to clinical trials
- Moderate travel (~20%)
- strong communication
- conflict resolution
- problem solving
- CTMS
- EDC
- eDiary
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