• Selection, qualification and training of external providers and clinical trial sites
• Submission to regulatory authorities and Independent Ethics Committee/Institutional Review Board (IEC/IRB)
• Support preparation of trial-specific documents, e.g. Informed Consent Form (ICF), submission document to IEC/IRB and regulatory authorities, training documents, manuals, Monitoring Plan, Clinical Study Report (CSR) appendices as well as support preparation of Confidential Disclosure Agreements and Clinical Trial Agreements including Legal and Compliance
• Review trial-specific documents with QC focus, e.g., Clinical Study Protocol (CSP), Project Plan, Monitoring Plan, Risk Management Plan

• Maintain Trial Master File (TMF)/eTMF, ensure readiness for audit/inspection and prepare TMF/eTMF for long-term archiving
• Internal reporting of payments to health professionals according to legal requirement (e.g., Sunshine Act)
• Support compliance with internal SOPs and relevant regulatory requirements, planning and controlling of budget and payments of external providers and trial sites as well as controlling of timelines

• University degree in life sciences or medical health (Bachelor) or other professional qualifications equivalent to university degree
• Experiences in coordinating and conducting clinical trials tasks and clinical study processes.
• Experiences as a clinical research associate and experiences in other areas in clinical research
• Advanced knowledge in relevant regulations (ICH GCP, DIN EN ISO, EU CTR, MDR, FDA, etc.)
• Advanced knowledge of medical or scientific terminology
• Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook) applications to prepare charts, tables, forms, reports, and presentations
• Fluent English skills

• Experience in exciting and international projects
• Continuous salary development
• Da Vinci Corporate Benefits
• On-the-job training and language courses
• Appreciation, motivation and commitment

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us!