VOLHA FALKENHAGEN
Berlin
Summary
Experienced clinical research professional adept at overseeing non-interventional and interventional studies at global sites. Skilled in conducting site initiation, maintenance, and close-out activities while ensuring compliance with ICH-GCP guidelines. Proven ability to build strong relationships with investigators and site staff to achieve study goals effectively and efficiently.
Overview
6
6
years of professional experience
Work History
Site Management Associate
ICON Plc (formerly PRA Health Sciences)
Langen
01.2021 - Current
- Collected, reviewed, and filed Essential Documents in compliance with the ICH-GCP guidelines.
- Ensured timely submission and approval of site regulatory documents by closely monitoring and recording them in CTMS.
- Conducted numerous TMF reviews, including those done post site closure.
- Trained personnel on new protocol changes, company monitoring model, and study specifics.
- Worked jointly with colleagues and sponsor to reach multiple database locks and secure FDA approval for one IP.
- Executed assigned duties autonomously by adhering to the company's or sponsor's SOPs and study plan documents. Managed routine tasks efficiently while handling inquiries from site personnel, IRB/IEC, and sponsors.
- Experience in diverse study fields including Oncology: Hematological and Prostate Cancers; Immunology, Genitourinary, and Neurology.
Postdoctoral Fellow
Lunenfeld Tanenbaum Research Institute, University of Toronto
Toronto
10.2018 - 01.2019
- Executed project planning and management in the field of oncology.
- Designed and carried out original experiments.
- Analyzed, interpreted, and summarized results for talks, poster presentations, and publications.
- Assisted in the development and growth of young talents through mentorship.
Education
Clinical Trial Manager, Post Graduate Program -
Parexel Academy
Berlin12.2020
Ph.D. - Laboratory Medicine And Pathobiology
University of Toronto
Toronto10-2018
Honours Bachelor of Science in Human Biology -
University of Toronto
Toronto06.2008
Skills
Soft Skills:
- Scientific Data Analysis
- Risk Assessment
- Team Collaboration
- Adaptability
- Self Organization
Software:
- Microsoft Office
- Various CTMS programs
- Various eTMF programs
Language:
- English
- German
- Russian - native
Interests
- Active lifestyle (Running, Bootcamp/HIIT, Stair Climbing, Volleyball)
- Travel
- Baking
Scientific Projects
Lunenfeld Tanenbaum Research Institute, University of Toronto, Toronto, Canada
05/2009-08/2009 Summer Student
09/2008-05/2009 Research year
References
References available upon request.
Timeline
Site Management Associate
ICON Plc (formerly PRA Health Sciences)
01.2021 - Current
Postdoctoral Fellow
Lunenfeld Tanenbaum Research Institute, University of Toronto
10.2018 - 01.2019
Clinical Trial Manager, Post Graduate Program -
Parexel Academy
Ph.D. - Laboratory Medicine And Pathobiology
University of Toronto
Honours Bachelor of Science in Human Biology -
University of Toronto
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