Overview
In this role you will oversee clinical operations for regional/global project delivery, coordinating CRAs and Investigator sites to ensure compliant, timely study execution. You will train CRAs, develop monitoring plans, and manage site performance, enrollment, and documentation. You’ll act as the primary liaison between CRAs and the clinical project team, shaping study tools and reporting. This is a global, cross-functional role with a focus on quality, performance, and service delivery.
Leistungen / Benefits
- Bonus
- Remote work / home-based role
- Accommodations for persons with disabilities available
Verantwortungsbereiche
- Oversee regional CRAs and investigator sites to ensure protocol and regulatory compliance
- Conduct co-monitoring visits and provide oversight of site performance and recruitment
- Develop and implement study tools, monitoring plans, and training materials
- Review visit reports, protocol deviations, and ensure timely, high-quality deliverables
- Coordinate CRA assessments and country/site progress updates with the project team
- Provide training and mentoring to CRAs on procedures, timelines, and guidelines
- Liaise with line managers for CRA allocation to sites and monitor utilization
- Support startup, feasibility, and vendor activities as required
- Contribute to financial processes such as revenue recognition and site payments
- Prepare presentations and participate in sponsor/kickoff/Investigator meetings
Zentrale Anforderungen
- 7-9 years of related experience with continuous training (or 4-6 years with substantial ongoing training)
- Strong experience with GCP, ICH guidelines, and local regulations
- Proficiency in EDC systems and MS Office
- Excellent written and verbal communication; strong interpersonal and organizational skills
- Ability to manage multiple tasks in a dynamic environment
- Experience with CRA oversight and site management, including training and mentoring
- proactive
- detail-oriented
- task-driven
- EDC systems
- MS Office
- GCP and regulatory knowledge
Clinical Operations Lead (Clinical Trial Manager) Arbeitgeber: Alimentiv
Als Arbeitgeber im Bereich klinisches Datenmanagement bieten wir eine dynamische und unterstützende Arbeitsumgebung, die auf Teamarbeit und kontinuierliche Verbesserung ausgerichtet ist. Unsere Mitarbeiter profitieren von umfangreichen Weiterbildungsmöglichkeiten, einem formellen Mentorenprogramm und einem leistungsbasierten Bonusprogramm, das ihre Erfolge anerkennt. Darüber hinaus fördern wir eine positive Unternehmenskultur, die auf Zusammenarbeit und Innovation abzielt, und bieten wettbewerbsfähige Vergütungspakete, die auf die regionalen Gegebenheiten abgestimmt sind.
