Petra is an experienced specialist with 25+ years in the industry, including 20 years specializing in medical devices across neurology/neuromodulation, cardiology, and orthopedics. Currently serving as Senior Clinical Data Manager, driving data quality and compliance in global clinical trials.
Petra has a proven track record in supporting international studies and contributing to successful programs at Boston Scientific and Cardialysis in roles spanning Data Management, Clinical Trial Management, and CRA management. Petra holds a doctorandus in Biological Psychology (Neuroscience) from the University of Utrecht, with a focus on (psycho)neuropharmacology and brain anatomy.
CORE COMPETENCIES
- Leading data management activities across global clinical trials, ensuring compliance and data quality
- Expertise in supporting database build and validation
- Skilled in data verification, query handling, and final data cleaning including quality audits
- Implementing risk-based and central monitoring strategies for proactive issue detection
- Writing and maintaining study-specific Data Management Plans, Data Review Guidelines, and CRF Completion Guidelines
- Generating accurate data outputs for analysis and regulatory submissions
- Delivering database user training and mentoring junior data managers and coordinators
- Managing CRAs, vendor oversight and performance reviews
- Preparing and supporting sponsor audits and governmental-led inspections
RECENT PROJECTS
- Lead Data Manager on global clinical trials
