I’m Alexandra L. Bohnenberger, a clinical operations professional with five years of experience in Phase I–III trials, site start-up, regulatory strategy, vendor coordination, and operational project management. I excel at coordinating cross-functional teams, managing timelines and budgets, and aligning CRO partners in global clinical environments. I have a strong background in GCP compliance, data quality, and regulatory submissions across EU studies. In my recent roles, I’ve led end-to-end startup activities, vendor and ethics committee coordination, and regulatory submissions, while keeping a sharp eye on financial tracking and document quality. I’ve also supported operational execution of trials across Germany, using CTMS and Veeva to maintain documentation and compliance across oncology, neurology, and autoimmune studies. I thrive in collaborative settings and am passionate about turning complex programs into well-running, compliant operations.

Alexandra L. Bohnenberger

I’m Alexandra L. Bohnenberger, a clinical operations professional with five years of experience in Phase I–III trials, site start-up, regulatory strategy, vendor coordination, and operational project management. I excel at coordinating cross-functional teams, managing timelines and budgets, and aligning CRO partners in global clinical environments. I have a strong background in GCP compliance, data quality, and regulatory submissions across EU studies. In my recent roles, I’ve led end-to-end startup activities, vendor and ethics committee coordination, and regulatory submissions, while keeping a sharp eye on financial tracking and document quality. I’ve also supported operational execution of trials across Germany, using CTMS and Veeva to maintain documentation and compliance across oncology, neurology, and autoimmune studies. I thrive in collaborative settings and am passionate about turning complex programs into well-running, compliant operations.

Available to hire

I’m Alexandra L. Bohnenberger, a clinical operations professional with five years of experience in Phase I–III trials, site start-up, regulatory strategy, vendor coordination, and operational project management. I excel at coordinating cross-functional teams, managing timelines and budgets, and aligning CRO partners in global clinical environments. I have a strong background in GCP compliance, data quality, and regulatory submissions across EU studies.

In my recent roles, I’ve led end-to-end startup activities, vendor and ethics committee coordination, and regulatory submissions, while keeping a sharp eye on financial tracking and document quality. I’ve also supported operational execution of trials across Germany, using CTMS and Veeva to maintain documentation and compliance across oncology, neurology, and autoimmune studies. I thrive in collaborative settings and am passionate about turning complex programs into well-running, compliant operations.

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Language

English
Fluent
German
Fluent
Portuguese
Beginner

Work Experience

Site Start-Up & Regulatory Specialist / FSP Clinical Operations Manager at SYN EOS Health GmbH
January 1, 2023 - Present
Managed end-to-end startup timelines, milestones, and deliverables for investigative sites; coordinated CROs, sponsors, ethics committees, and regulatory authorities; oversaw financial tracking, budgeting alignment, and essential document quality; identified operational risks and ensured on-time regulatory approvals.
Clinical Trial Associate at ICON Strategic Solutions
January 1, 2020 - January 1, 2022
Supported operational execution of Phase I–III trials across Germany; coordinated vendors, sites, and internal teams to maintain study timelines; utilized CTMS and Veeva for documentation, data tracking, and compliance; ensured EU GCP and ICF compliance across oncology, neurology, and autoimmune studies.
Research and Innovation Fellow at Federal University of Rio Grande do Sul
January 1, 2017 - January 1, 2018
Explored causal effects of meteorological variables and bacterial meningitis; data analysis in SPSS and MATLAB; collaboration with Brazilian research groups; facilitated cultural and language exchange.
Patient Care Technician at Phoenix Children's Hospital
January 1, 2015 - January 1, 2017
Obtained routine vital signs and assisted nurses with oncology and medical-surgical clinic procedures; collected saliva samples, monitored vitals, and documented findings as part of an Animal-Assisted Therapy study.
Accounts Exchange Member at AIESEC
January 1, 2014 - January 1, 2015
Managed and processed international internship applications; established internal and employer communications, housing arrangements, transportation, visa setup, banking, and cultural immersion once interns arrived.
Neonatal Intensive Care Volunteer at Banner Health Hospitals
January 1, 2011 - January 1, 2013
Assisted nurses in medical procedures; cared for neonates.
Math Tutor at Mesa Community College
January 1, 2011 - December 31, 2011
Provided tutoring support to college algebra students.
Emergency Medical Technician Captain at ASU EMS Program
January 1, 2014 - January 1, 2015
Trained and led new EMTs in campus operations, patient care, and emergency response on campus.
Emergency Medical Technician at ASU EMS
January 1, 2011 - December 31, 2011
Responded to emergencies on campus during athletic events and emergency response shifts.
Research Projects – Capstone at Arizona State University, Phoenix, AZ
January 1, 2016 - December 31, 2016
Capstone: an interdisciplinary analysis of meningococcal immunization requirements for college students in the United States to craft legislative requirements for the State of Arizona.
Research Projects – PTSD Integration Study at Arizona State University, Tempe, AZ
January 1, 2015 - December 31, 2015
An interdisciplinary research project that explored system failures hindering reintegration of military veterans with PTSD into society.
Field Research – Western Rattlesnake Behavior at Mesa Community College
January 1, 2011 - December 31, 2011
Field research and data analysis with radio-tracking to determine home range of western rattlesnakes.

Education

MD at University of Düsseldorf
January 1, 2018 - January 1, 2020
MSc at Arizona State University
January 11, 2030 - December 1, 2016
BSc Biological Sciences at Arizona State University
January 11, 2030 - May 1, 2015
Volunteer/EMS Education at Arizona State University – Emergency Medical Services
January 1, 2012 - January 1, 2016

Qualifications

US AID Research and Innovation Fellowship
January 1, 2017 - December 31, 2017
National Collegiate EMS Conference Scholarship
January 1, 2014 - December 31, 2014
Honors Scholarship
January 1, 2011 - May 1, 2012

Industry Experience

Healthcare, Life Sciences, Professional Services, Education