Clinical Research Manager

In this role you lead trial monitoring staff in-country, ensuring high-quality clinical operations and adherence to ICH/GCP. You work with regional leaders to meet timelines and quality standards, while contributing to start-up efforts and local expertise. This position combines people management, site collaboration, and process optimization to support oncology trials. You will drive operational excellence and support site activation, enrolment goals, and inspection readiness, within a mission-focused company.

• Manage line of CRAs and plan/assign their workload
• Participate in hiring and onboarding of new staff
• Oversee training programs and track development
• Oversee quality of clinical work through regular reviews
• Provide country-specific study start-up expertise to teams
• Review study start-up documents and site materials
• Collaborate to achieve timely IRB/EC submissions and TMF completeness
• Support feasibility studies, site identification, and evaluation
• Conduct accompanied CRA visits to assess performance and escalate issues
• Identify site issues, propose CAPAs, and drive improvement initiatives
• Monitor workload and quality metrics; report findings to leadership
• Contribute to Clinical Operations strategy and KPI tracking
• Travel up to 30-40%
• Ensure compliance with regulatory and internal SOPs

• Bachelor’s degree in a scientific, medical or healthcare discipline
• Minimum 5–7 years of progressive clinical operations experience in biotech/pharmaceuticals
• Past clinical trial experience with leadership/management responsibility
• Experience in oncology is highly recommended
• Ability to work independently and manage multiple priorities
• Strong interpersonal and organizational skills
• Fluent in German and the country language (spoken and written)
• Minimum 2 years of line management in pharma or CRO
• Willingness to travel up to 30-40%
• Experience with site initiation, TMF, and regulatory submissions

• strong leadership and mentoring abilities
• excellent interpersonal skills
• high organizational capability
• ICH/GCP compliance
• IRB/EC submission processes
• TMF management and documentation