Summary
Overview
Work History
Education
Skills
Timeline
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MANDIE GUIDUGLI

Covington,KY

Summary

Results-driven Senior Lead Data Manager with over 9 years of experience managing complex Phase I-IV clinical trials across multiple therapeutic areas in CRO environments. Proven track record of leading global data management teams, building client trust, and delivering clean data sets on time and within budget. Adept at collaborating with cross-functional teams and representing DM in sponsor and regulatory interactions.

Overview

10
10
years of professional experience

Work History

SENIOR LEAD DATA MANAGER

ADVANCED CLINICAL, LLC
11.2023 - Current
  • Led sponsor meetings and presented metrics and risk mitigation plans.
  • Led a team of 4 Clinical Data Associates and collaborated with biostats, medical writers, CTMs and CRAs
  • Designed and reviewed EDC CRFs; authored eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications, and external data transfer specs.
  • Prepared all data cleaning and data status documentation; including, but not limited to metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
  • Perform/provide oversight of user acceptance testing for assigned projects
  • Responsible for project budget oversight, revenue recognition, forecasting and billing/invoicing review/approval
  • Provide training and mentoring for other Leads and Clinical Data Associates
  • Managed vendor relationships to ensure timely delivery of high-quality products and services at competitive prices.

DATA SERVICES SENIOR IMPLEMENTATION CONSULTANT

MEDIDATA SOLUTIONS
11.2021 - 11.2023
  • eSupport planning and conduct of eCOA clinical studies across phases (I-IV)
  • Provide solid Data Management expertise and guidance during decision making and/or issue resolution process
  • Contribute to cross-functional expectations on data quality and data cleaning activities incorporated into the Data Management Quality Plan
  • Provide ongoing data cleaning to identify issues/risks in data quality and data cleaning performance
  • Support and maintain strong alliances with other functions and CRO partners
  • Deliver high quality Clean Databases
  • Initiates the DTS package and contributes to the set-up and testing of the eCRF incl. Edit Checks, data listings, and reports, in close cooperation with study team
  • Serves as the key subject matter expert and project lead on implementation topics related to data management activities. (e.g. mentoring junior staff, training team members, leading or contributing to expert working groups)

LEAD DATA MANAGER

ADVANCED CLINICAL, LLC
11.2020 - 11.2021
  • Additional Responsibilities: perform other duties requested by management (Also, all tasks I was performing as a Data Coordinator)
  • Serve as primary point of contact for data management projects.
  • Coordinate and ensure the accuracy and completeness of activities for data management assigned study team members.
  • Create and maintain project timelines.
  • Strong understanding of departmental and company procedures; ability to guide others on procedures.
  • Prepare data transfer agreements and coordinate the receipt of data transfers.

CLINICAL DATA COORDINATOR III

MEDPACE
12.2015 - 11.2020
  • Work on multiple studies with separate and distinct data handling rules.
  • Issue queries to sites, and generated medical coding queries.
  • Perform listing reviews, AE-SAE reconciliation.
  • Create, review and update Case Report Forms, Edit Check Specifications and CRF Completion Guidelines during the study trial.
  • Perform Data Access Testing and User Access Testing to ensure accuracy of the database.
  • Work regularly with SAS programmers to develop and revise edit checks and listing output to ensure clean data.
  • Assured Good Clinical Practices, investigator integrity and compliance with all study procedures.

Education

BACHELORS OF SCIENCE - Exercise Science, Minor in Science

NORTHERN KENTUCKY UNIVERSITY
HIGHLAND HEIGHTS, KY
12-2014

Skills

  • Excel
  • Microsoft package
  • Audit and Regulatory Inspection Readiness
  • CDASH/SDTM Mapping
  • CRO-Sponsor Relations
  • EDC Systems- Medidata Rave
  • EDC Systems- Zelta
  • Project Lifecycle Oversight
  • Query Management
  • Data Cleansing
  • Data quality assurance
  • Data governance

Timeline

SENIOR LEAD DATA MANAGER

ADVANCED CLINICAL, LLC
11.2023 - Current

DATA SERVICES SENIOR IMPLEMENTATION CONSULTANT

MEDIDATA SOLUTIONS
11.2021 - 11.2023

LEAD DATA MANAGER

ADVANCED CLINICAL, LLC
11.2020 - 11.2021

CLINICAL DATA COORDINATOR III

MEDPACE
12.2015 - 11.2020

BACHELORS OF SCIENCE - Exercise Science, Minor in Science

NORTHERN KENTUCKY UNIVERSITY

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