Overview
In this role, you will lead clinical trial operations for sponsor-specific partnerships in Germany, overseeing site and central monitoring with a focus on patient safety and data integrity. You will collaborate with cross-functional teams to manage risks, budgets, and timelines, ensuring regulatory and GCP compliance. You’ll engage with investigators and sites, drive study milestones, and optimize monitoring and trial management processes. This position offers impactful work within a global organization that supports patient progress and innovative drug development.
Leistungen / Benefits
- career development
- inclusive culture
- total rewards program
Verantwortungsbereiche
- Oversee site management and central monitoring deliverables with focus on patient safety, protocol/GCP/regulatory compliance and data integrity
- Manage site interactions from activation to closeout, including patient recruitment and investigator payments as needed
- Identify data and process risks, and implement mitigations using the RACT framework
- Review study scope, budget, and protocol content; ensure CRAs/CeMs understand contractual obligations
- Escalate risks to project manager related to timeline, quality, budget, or scope
- Present and participate in key meetings (e.g., Kick Off) and coordinate with Study Start Up, Patient Recruitment, and Data Management
- Develop and maintain clinical study tools/templates (e.g., Clinical Monitoring Plan); ensure CTMS and dashboards are ready and usable
- Provide initial and ongoing training on protocol specifics, CRF completion, dashboards, SOPs, data plans, and timelines
- Oversee resource allocations for CRAs and Central Monitors; ensure quality of monitoring deliverables
- Monitor and review CTMS/EDC/eDiary/ePROs/TMF/IVRS dashboards to reflect timely operational execution
- Ensure monitoring strategy alignment with CMP/SMP and risk plans; ensure staff compliance and delivery
- Interact with clients and other functions, providing status updates and solutions for protocol execution obstacles
- Support inspection readiness and QA activities; develop corrective action plans as needed
- Mentor and coach CTMs on clinical delivery and risk evaluation
- May coordinate activities for larger trials or across a portfolio; travel up to ~20%
Zentrale Anforderungen
- Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
- Ability to lead and align teams to achieve project milestones
- Experience working in an international environment
- Expertise in site management and monitoring (clinical or central)
- Knowledge of risk-based monitoring (preferred)
- Understanding of clinical trial management financial principles and budget management
- Knowledge of GCP/ICH guidelines and regulatory requirements
- Good computer skills; strong conflict resolution and problem-solving abilities
- Ability to apply risk management to identify and mitigate threats; critical thinking to resolve issues
- Moderate travel (~20%)
- conflict resolution
- problem-solving
- leadership
- CTMS
- EDC
- eDiary
Clinical Trial Managers (SMLs) sponsor dedicated in Germany in Magdeburg Arbeitgeber: Syneos Health
Syneos Health ist ein hervorragender Arbeitgeber, der sich leidenschaftlich für die Entwicklung seiner Mitarbeiter einsetzt und eine inklusive Unternehmenskultur fördert, in der jeder authentisch sein kann. Mit einem starken Fokus auf Karriereentwicklung, technische Schulungen und Anerkennung bietet das Unternehmen zahlreiche Möglichkeiten zur persönlichen und beruflichen Entfaltung. In Nordostdeutschland gelegen, profitieren Mitarbeiter von einem dynamischen Arbeitsumfeld, das Innovation und Zusammenarbeit fördert, um gemeinsam bedeutende Fortschritte im Gesundheitswesen zu erzielen.
