Experience

Miltenyi Biomedicine

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Clinical Trial Manager

  • Oct 2021 - Present



Merus N.V.

• Netherlands
• Biotechnology Research
• 100 - 200 Employee

• Clinical Trials Manager

  • May 2019 - Oct 2021



uniQure

• Netherlands
• Biotechnology Research
• 400 - 500 Employee

• Sr. Clinical Trial Associate

  • Jan 2018 - May 2019

  • Lead the development and design of FIH Phase I/II trial in Huntington Disease patients, including the submission of an IND. • Developed and Finalized Clinical Trial Documents, including a Clinical Trial Protocol, Investigator’s Brochure, and ICF for a Phase I/II trial. • Lead regular cross-functional Clinical Program Team meetings and Clinical Trial Team meetings to drive program development. • Selected and managed a variety of vendors, including CRO’s, Central Labs, Medical Writers, and others. • Collected site feasibility data to drive site selection for a Phase I/II trial and participated in Site Qualification Visits. • Supported site feasibility, site selection, and vendor development to initiate a PhIIb/PhIII trial. • Participated in neurologist, neurosurgeon, and patient advisory boards to enrich program development. • Aided in the development of EDC systems for multiple projects. • Supported the management of the Trial Master File (TMF), i.e. set up and maintenance in line with ICH/GCP. • Supported study finance processes. • Collected and collated the data from the different departments needed in the management reports. • Delivered routine reports, reviewing for accuracy and potential escalation items. • Supported in the preparation of Ethics Committee submission packages within set timelines. Show less



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Monitoring Associate

  • Jul 2016 - Dec 2017

  • Regularly monitored site level data in clinical EDC systems to ensure data was accurate and precise. • Prepared and collected essential regulatory documents (Site Regulatory Package) for review and approval. • Negotiated and supported the collection of the ICF while working as a liaison between the Clinical Trial Specialist (CTS) and site when needed for in-depth language negotiation. • Ensured study documents were submitted to Trial Master File as outlined in Central Files Maintenance Plan. • Ensured project tracking and Clinical Trial Management System (CTMS) were current and accurate. • Performed work according in accordance with ICH Guidelines, GCPs, local Regulatory Agency requirements and PAREXEL and Sponsor SOPs, as applicable. • Comprehensive knowledge of Adverse Event and Serious Adverse Event (AE/ SAE) reporting timelines. • Collaborated closely with supporting team members on site issues or pending action items. • Ensured site staff had required access to relevant study systems (i.e. EDC, IVRS, SIS). Show less



Tufts Medical Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Hematology Laboratory Technician

  • Jan 2014 - Aug 2015

  -Conducted blood specimen analysis to investigate clotting factors, white blood cell differentials, and sedimentation rates in patient blood samples. -Reported abnormal test results to ordering physician. -Took a lead role in obtaining and analyzing basic coagulation tests as part of a team to conduct beta-testing on new coagulation technologies. -Conducted blood specimen analysis to investigate clotting factors, white blood cell differentials, and sedimentation rates in patient blood samples. -Reported abnormal test results to ordering physician. -Took a lead role in obtaining and analyzing basic coagulation tests as part of a team to conduct beta-testing on new coagulation technologies.



Northeastern University Biology Department

• Boston

• Research Assistant

  • Jul 2012 - Aug 2015

  -Worked as part of a team to conduct research investigating circadian cycles in mutant and normal lab animals. -Conducted 2-way ANOVA analysis on data using SAS and SPSS software. -Aided in the construction and revision process of a research paper. -Examined respiratory rates of the mentioned lab animals to analyze the differences in oxygen consumption between the normal and mutant specimens. -Counted white blood cells in bats by hemocytometers and blood smears to analyze immune function. Show less



Marino Center

• Cambridge, MA

• Medical Assistant

  • Jan 2012 - May 2012

  -Obtained vital signs and completed necessary tests, including electrocardiograms and vaccinations. -Documented the results of all vital signs and tests in a computer database system. -Stocked equipment and linens as needed and cleaned rooms. -Obtained vital signs and completed necessary tests, including electrocardiograms and vaccinations. -Documented the results of all vital signs and tests in a computer database system. -Stocked equipment and linens as needed and cleaned rooms.