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Data and Regulatory Manager Resume Example

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DATA AND REGULATORY MANAGER
Skills
  • Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology
  • Excellent written and verbal communication skills to express complex ideas to study personnel at research and sponsors.
  • Ability to handle several priorities within multiple, complex trials.
  • Knowledge of electronic data capture including basic data processing functions.
  • Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
  • Have worked with IQVIA/Roche sponsors in previous clinical trials
  • Four+ years of clinical trials
  • Demonstrated ability to form strong functional relationships with sponsor and team members
Professional Summary

My career objective is to conduct high-quality systematic reviews of existing trials and public datasets with attention to enrolled patient populations, study design, outcome endpoints and adverse event reporting to identify potential limitations and biases of contemporary clinical trials. Well-versed in coordinating regulatory and data abstraction, completing calculations and optimizing quality assurance standards. Skilled at building oversight systems, managing audits and setting standard operating processes in full compliance with Good Clinical Practices.

Work History
Data and Regulatory Manager, 07/2019 to Current
Oregon Health & Science University - Portland, Oregon
  • Department/Division: Hematology and Medical Oncology
  • Worked with internal team members to accomplish regulatory goals and achieve full compliance with Good Clinical Practices
  • Managed all regulatory needs for products such as IIT/Industy studies, maintaining protocol amendments, submission to IRB and study start-up/close out.
  • Abstracted data, compiled information and submitted to EDC and CRFs.
  • Participates in the preparation and execution of Phase I-IV Clinical Trials
  • Works closely with sponsor Clinical Trial Manager (CTM) and/or CRA to ensure all monitoring activities are conducted according to study requirements/protocol
  • Management and scheduling of Pre-SIV, SIV, Close out and Monitoring visits of over 30+ Clinical Trials
  • Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
  • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation
  • Serves as primary contact between Sponsor and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
  • Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
VP Research Administration, 11/2016 to 06/2019
Oregon Health & Science University - Portland, Oregon
  • Department/Division: Vascular Surgery
  • Managed quality data, including on-site evaluations, internal audits and research publications.
  • Resolved conflicts and queries in regional EDC for Vascular Quality Initiative.
  • Assists with, and attends, Aorta Symposium Investigator Meetings done at site.
  • Handled IDE studies and maintained sponsor relations for compassionate use studies.
  • Assist Chief Director with various clinical trials
  • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation
  • Serves as primary contact between Sponsor and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
Vascular Surgery Intern, 02/2016 to 11/2016
Oregon Health & Science University - Portland, Oregon
  • Department/Division: Vascular Surgery
  • Managed quality data, including on-site evaluations, internal audits and research publications.
  • Resolved conflicts and queries in regional EDC for Vascular Quality Initiative.
  • Monitor Aorta Symposium Investigator Meetings done at site.
  • Handled IDE studies and maintained sponsor relations for compassionate use studies.
  • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation
  • Serves as primary contact between Sponsor and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
Education
Bachelor of Arts: : Microbiology And Philosophy, 07/2015University of Washington - Seattle, WA
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Resume Overview

Companies Worked For:

  • Oregon Health & Science University

School Attended

  • University of Washington

Job Titles Held:

  • Data and Regulatory Manager
  • VP Research Administration
  • Vascular Surgery Intern

Degrees

  • Bachelor of Arts : : Microbiology And Philosophy , 07/2015

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