Overview
In this role you lead trial monitoring staff (CRAs) within the country to ensure high-quality clinical trial execution. You work closely with the Regional Clinical Operations Manager to meet study timelines and quality standards, while supporting start-up and local expertise. You will mentor and develop direct reports, oversee training, and review start-up documents, site activation, and enrollment progress. You drive operational excellence and innovation in oncology trials, shaping country-level clinical operations and risk mitigation.
Verantwortungsbereiche
- Line manage CRAs and oversee performance and development
- Participate in hiring and resource allocation for clinical studies
- Ensure adherence to ICH/GCP, local regulations, and SOPs
- Collaborate with Regional Clinical Operations Manager to meet timelines and quality standards
- Provide country-specific study start-up expertise and review essential documents (ICF, drug labels, templates)
- Contribute to feasibility, site identification, selection and evaluation
- Perform accompanied CRA visits to assess performance and escalate risks
- Monitor workload and quality metrics; implement CAPAs as needed
- Support site activation, enrollment goals, and TMF completeness
- Promote operating excellence and drive improvements in clinical operations
- Mentor junior staff, conduct performance appraisals, and manage escalation
- Travel up to 30-40%
- Ensure IRB/EC submissions are timely and complete
Zentrale Anforderungen
- Bachelor degree in scientific/medical/healthcare discipline
- Minimum 5-7 years in clinical operations in biotech/pharmaceuticals
- Experience in a management/leadership role in clinical trials
- Oncology experience highly recommended
- Fluent in German and English (spoken and written)
- Ability to manage multiple priorities in a fast-paced environment
- 2+ years of line management in pharma/CRO preferred
- Strong interpersonal and organizational skills
- Willingness to travel 30-40%
- interpersonal skills
- strong organizational abilities
- leadership and people management
- ICH/GCP knowledge
- TMF completeness
- IRB/EC submissions
Clinical Research Manager in Dortmund Arbeitgeber: BeiGene
BeOne ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet, in der Mitarbeiter ihre Fähigkeiten weiterentwickeln und an bedeutenden Projekten zur Bekämpfung von Krebs mitwirken können. Mit einem klaren Fokus auf kontinuierliches Lernen und Entwicklung fördert BeOne eine Kultur der Zusammenarbeit und Innovation, während die strategische Lage in Deutschland den Zugang zu einem breiten Netzwerk von Fachleuten und Ressourcen ermöglicht. Die Möglichkeit, an der Gestaltung von Schulungsprogrammen für neue Produkte und Marktstrategien mitzuwirken, macht diese Position besonders attraktiv für engagierte Fachkräfte.
