Debby Schutte

About Debby Schutte

Sr. Clinical Operations Lead with 15 years’ experience working with Clinical Research Organizations (CRO). I began my career in 2008 with Kendle International as a Sr. Administrative Assistant for the departments of Clinical Trial Regulatory, Document Maintenance, and Investigator Site Contracts. In 2011 I moved into a Site Start-Up and Regulatory Specialist position with INC Research. I joined Quintiles on May 2014 as a Site Management Specialist II, then promoted to Site Manager 2 April 2015 which was a Job title change with promotion. Quintiles merged with IMS to become QuintilesIMS and on November 7, 2017 Quintiles & IMS became IQVIA. March 2017 I promoted into the position of Site Identification Lead, August 2018 promoted to Assoc. Site Management Lead and in less than two years, April 2020, I was promoted as Site Management Lead. My title changed to Clinical Operations Lead in 2020. I recently promoted into my current position as a Sr Clinical Operations Lead July 2021.My industry experience includes Phase I through Phase IV study designs.

Experience

1. Sr Clinical Operations Lead

   IQVIA

   Jul 2021 — Present · US

   As a Sr. Clinical Operations Lead I independently direct the execution of Real World studies by applying clinical research experience and decision making skills to proactively set goals and tangible expectations for project team members. I provide leadership of the operations team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our Standard Operating Procedures (SOPs), policies and practices

Education

• University of Cincinnati/Raymond Walters campus

  Clinical Trial Research

• Indiana Wesleyan University

  Associates

Skills

• Cardiology
• Good Clinical Practice (Gcp)
• CRO Management
• Regulatory Requirements
• Regulatory Affairs
• Lifesciences
• Clinical Development
• Pharmaceutics
• Clinical Trials
• Infectious Diseases
• Clinical Data Management
• Oracle Clinical
• Medical Writing
• Edc
• Therapeutic Areas
• Clinical Operations
• 21 Cfr Part 11
• Ctms
• Ich-Gcp
• CRO
• Hematology
• Drug Development
• Life Sciences
• Gcp
• Biopharmaceuticals
• Clinical Monitoring
• Rheumatology
• Clinical Study Design
• Phase I
• Pharmacovigilance
• Medical Affairs
• Endocrinology
• Dermatology
• Clinical Research
• Clinical Pharmacology
• Immunology
• Vaccines
• Inform
• Data Management
• Regulatory Submissions