2019 - 2021: Achieved optimal site performance
Place of work: Mannheim, Germany
Customer: PRA Health Sciences
Tasks:
Conducted all monitoring visits from site selection to close-out by leading independent Clinical Monitoring of Phase II/III trials in oncology, immunology, and gastroenterology. Oversaw management of multiple sites across diverse protocols. Gathered, reviewed, and updated information for documenting progress reports. Streamlined operations without major quality findings whilst steering 15 trial sites across five global Phase II/III studies.
Place of work: Munich, Germany
Customer: DOCS International GmbH
Tasks:
Performed independent Clinical Monitoring of Phase II/III trials in oncology and immunology as well as documented all site management activities from site selection to closure in monitoring visit reports. Determined improvement areas and addressed site issues by implementing corrective and preventive actions (CAPAs) in collaboration with project teams. Provided comprehensive training to site teams, covering all aspects of studies, ICH-GCP, and regulatory requirements.
2012:
Hamburg University of Applied Sciences, Hamburg, Germany
Bachelor of Science in Health Sciences
Profile:
2019 - 2021: Achieved optimal site performance
Place of work: Mannheim, Germany
Customer: PRA Health Sciences
Tasks:
Conducted all monitoring visits from site selection to close-out by leading independent Clinical Monitoring of Phase II/III trials in oncology, immunology, and gastroenterology. Oversaw management of multiple sites across diverse protocols. Gathered, reviewed, and updated information for documenting progress reports. Streamlined operations without major quality findings whilst steering 15 trial sites across five global Phase II/III studies.
Place of work: Munich, Germany
Customer: DOCS International GmbH
Tasks:
Performed independent Clinical Monitoring of Phase II/III trials in oncology and immunology as well as documented all site management activities from site selection to closure in monitoring visit reports. Determined improvement areas and addressed site issues by implementing corrective and preventive actions (CAPAs) in collaboration with project teams. Provided comprehensive training to site teams, covering all aspects of studies, ICH-GCP, and regulatory requirements.
2012:
Hamburg University of Applied Sciences, Hamburg, Germany
Bachelor of Science in Health Sciences
Profile: