YOUR JOB DUTIES
- Leading a team of assigned CRAs across different countries, you coordinate and guide their work to ensure study milestones are delivered efficiently, accurately, and on time
- Actively participating in the creation of clinical monitoring plans, monitoring tools, visit report annotations, and CRA training materials, you also promote the ongoing enhancement of monitoring SOPs and templates to make monitoring activities more efficient and intelligent
- With your experience and expertise, you train and mentor CRAs on study- and monitoring specific requirements, maintaining full training compliance and building a culture of excellence and accountability
- Conducting co-monitoring visits internationally or, if necessary, on-site visits in the DACH region, including SQV, SIVs, IMVs or COVs, to guarantee consistency, quality, and strong relationships with our clinical sites throughout
- Assisting each study in getting off to a good start and maintaining timelines by supervising regional start-up and feasibility activities
- Working closely with clinical project managers, study coordinators, and data managers, you share insights, overcome challenges, and continuously drive best practices forward
- You also ensure that CRAs always keep their sites inspection-ready, including maintaining a complete and compliant Investigator Site File and Trial Master File (TMF) for potential health authority inspections