20+ years of international experience in clinical project management, with a strong focus on regulatory compliance and successful trial delivery
Expert in clinical start-up, site management, and contract negotiations, ensuring streamlined processes and adherence to timelines and budgets
Comprehensive knowledge of SOP development, submissions, and vendor oversight, backed by hands-on consulting experience
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Overview
- Availability
- 01.07.2025; full-time; on-site & remote
- Qualification
- GCP Fundamentals, IQVIA Trainings Program EU Clinical Trial Regulation no 536/2014 , IQVIA Trainings Program M.Sc. Genetics, University of Vienna
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Clinical Project Management, Site Management, Contract Negotiations, SOP Development, Vendor Management, Monitoring, Submissions, Pharma, Biotechnology
Key-Facts
Extract from previous activities
Pharmaceutical Company
Clinical Research Associate
Conducted on-site clinical monitoring for ongoing Phase II and III clinical trials
Performed Qualification and Site Initiation Visits to ensure site readiness and regulatory compliance
Provided continuous support and oversight to study sites throughout the trial lifecycle
Prepared essential study documentation, including detailed Monitoring Visit Reports and follow-up correspondence
Pharmaceutical Company
Clinical Contracts Coordinator
Drafted site-specific clinical trial agreements, including all necessary addenda and amendments
Led and coordinated the entire contract negotiation process through to final signature
Maintained thorough documentation of negotiation progress and contract status
Represented client interests in compliance and costeffectiveness discussions with local study teams, Clinical Quality/Compliance Managers, and legal advisors
Provided expert support to project leads on budget planning and negotiation strategies