Summary
Overview
Work History
Education
Skills
Accomplishments
Clinical Trial Systems
Clinical Research Therapeutic Areas
Ich Gcp Training
Affiliations
Certification
Languages
Timeline
Generic

Jennifer Bournique

Ave Maria,FL

Summary

Knowledgeable RBQM Implementation Expert with more than 20 years of Clinical Research experience including guiding strategic initiatives that enhanced operational efficiency and fostered organizational growth. Demonstrated expertise in Leadership, Strategic Planning, Operations, Process Improvement, Risk Management, Critical Data Identification and Monitoring Oversight Planning and Execution.

Overview

38
38
years of professional experience
1
1
Certification

Work History

Vice President, Consulting Service

CluePoints
10.2022 - 12.2024
  • Contribute to the strategic vision and alignment of CluePoints Consulting Services team, lead the Consulting Services team in identifying and achieving initiatives aligned with company goals through the use of Key Performance Indicators
  • Drive continuous improvement and support Research, Customer Success and Product Development teams in meeting their goals and objective
  • Build the reputation of the Consulting Services team within CluePoints and across the industry to further establish CluePoints as the top RBQM solution provider
  • Support clients with the implementation of their RBQM processes and procedures including initial build-up, process development and gap analysis as well as stakeholder mapping and change management considerations

Central Monitoring Consultant

CluePoints
01.2022 - 09.2022
  • Provide consultation and operational support as needed to customers in their RBQM adoption including coaching in performing Risk Assessments, identifying critical data and processes, specifying KRIs/QTLs and issue management
  • Support internal colleagues such as Data Analysts, Customer Success and Business Development in the interpretation and execution of RBQM related assignments
  • Participate in the continuous improvement and development of product solutions and operational processes

Associate Director, Study Lead Country Operations

Alexion AstraZeneca Rare Disease
11.2020 - 01.2022
  • Accountable for coordinating and driving activities as primary point of contact for Country Operations including feasibility, start-up, monitoring, site oversight, quality and study specific deliverables as well as acting as a liaison for other key stakeholders for relevant site and monitoring issues at the country level
  • Responsible for utilizing and interpreting data from analytic tools, in country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks

Associate Director, Risk Management and Central Monitoring

Janssen Pharmaceutical Companies of Johnson & Johnson
09.2018 - 11.2020
  • Led and championed risk management standards as well as improvement of internal systems, tools and processes while influencing RBQM functional area strategy
  • Led process improvement working groups and initiatives across Functional Area, Therapeutic Areas, and Sectors including calculation and presentation of department KPIs to leadership
  • Led a team of up to 5 personnel, supervising daily performance as well as training and improvement plans.

Manager, Risk Management and Central Monitoring

Janssen Pharmaceutical Companies of Johnson & Johnson
09.2017 - 09.2018
  • Managed group activities across phases of Analytical Risk-Based Monitoring (ARBM) trial design and execution including start-up, execution and close out, liaising with Program Teams and internal cross-functional colleagues
  • Trained, developed and evaluated staff performance
  • Proactively assisted in development and implementation and continuous improvement of the ARBM activities and processes
  • Managed and motivated employees to be productive and engaged in work.

Senior Specialist, Risk Management and Central Monitoring

Janssen Pharmaceutical Companies of Johnson & Johnson
01.2016 - 09.2017
  • Executed the Analytical Risk-Based Monitoring (ARBM) processes and activities for high/medium complexity trials in conformance to all relevant laws, regulations, guidelines, policies and procedures including study set-up and management of central monitoring activities
  • Led the preparation, conduct and follow-up of the cross-functional Central Monitoring Working Group (CMWG) for ARBM studies and shared responsibility for the quality of the data
  • Contributed to process improvement of the ARBM model, provided training to employees, and reviewed the work of others

Central Monitoring Specialist

DOCS Global for Janssen Pharmaceuticals
04.2015 - 01.2016
  • Executed the Analytical Risk-Based Monitoring (ARBM) processes and activities for high and/or medium complexity trials in conformance to all relevant laws, regulations, guidelines, policies and procedures including study set-up and management of central monitoring activities

Manager, Study Monitoring

Roche Diagnostics Corporation
10.2011 - 03.2015
  • Managed internal and external monitoring resources, trained and coached staff on departmental SOPs, Good Clinical Practices and other applicable regulations
  • Developed and reported KPIs to support continuous improvement
  • Developed and implemented flexible global resourcing solutions based on a Risk-Based Monitoring approach
  • Served as CAPA Coordinator in CAPA resolution and assisted with audits of Investigator Sites and Clinical Research Organizations in partnership with Quality Assurance
  • Owner of local procedures requiring knowledge of the document review and approval process
  • Member of global Clinical Operations Quality team, Medical and Scientific Affairs Operating Committee, and Extended Leadership Team

Senior Data Coordinator

Roche Diagnostics Corporation
10.2007 - 09.2011
  • Primary interface between the global Roche Diagnostic Clinical Information Management Services Group (CIM) and study teams to drive generation of clinical study databases, reporting requirements, and post-production change management
  • Responsible for user training, support and compliance activities, and interactions between CIM and other Clinical Operations specific software
  • Represented the needs of Indianapolis Clinical Operations in the global Clinical Operations data handling team
  • Maintained Study Management and Project Management activities to ensure knowledge of current processes, timelines and budgets
  • Responsible for training and oversight of day-to-day activities for various contract workers (CRAs and Project Management)

Clinical Research Associate

Roche Diagnostics Corporation
10.2001 - 10.2007
  • Provided support and training for Clinical Trials Information System and served as departmental liaison with the Clinical Information Management group
  • Managed, monitored, provided training and collected data from in-vitro diagnostic study sites (IDE, PMA and 510K) located throughout the United States
  • Supervised one contract data entry person, March 2002 through January 2003

Research Scientist

Roche Diagnostics Corporation
01.1991 - 09.2001
  • Developed, applied and evaluated clinical chemistry and Drugs of Abuse reagents for automated laboratory analyzers according to RDC design control process.

Scientist 1

Roche Diagnostics Corporation
01.1989 - 01.1991
  • Developed, applied and evaluated clinical chemistry and Drugs of Abuse reagents for automated laboratory analyzers according to RDC design control process
  • Collected data for 510(k) submissions and performance evaluation reports for Reflotron tests strips
  • Collected data for code assignments for blood glucose testing strips

Associate Chemist

Becton Dickinson Diagnostic Instrument Systems
08.1988 - 11.1988
  • Adapted manual enzyme immunoassays to automated analyzers
  • Collect data for 510(k) submission

Research and Development Chemist

Quad Pharmaceuticals
10.1987 - 07.1988
  • Formulated generic parenteral pharmaceutical products
  • Collected data for Abbreviated New Drug Applications
  • Prepared Abbreviated New Drug Applications

Lab Technician

Cargill Corn Milling Division, Fructose Lab
02.1987 - 10.1987
  • Completed in process quality control of 95% dextrose production

Education

Bachelor of Science - Chemistry

Indiana State University
Terre Haute, IN
12.1986

Skills

  • Collaborative Leadership

  • Strategic Decision-Making

  • Critical thinking

  • Coaching and mentoring

  • Complex Problem-solving

  • Strategic planning

  • Outcome-Oriented

  • Effective Documentation Practices

  • Risk management

  • Operational Efficiency Enhancement

  • Coaching and Guidance

  • Knowledge of Best Practices

  • Cross-functional team leadership

  • Operational Procedure Development

Accomplishments

Built a consulting services team to provide support to both internal and external CluePoints customers in support of RBQM implementation and execution including both software related activities (validation, single sign-on, data integration, etc.) and processes and skills needed to successfully utilize the RBQM and CluePoints software (Process mapping, review and gap analysis, Risk Management, Critical Data Identification, Central Monitoring, etc.).

Clinical Trial Systems

  • Medidata RAVE EDC
  • Sierra Scientific CRIS
  • Medidata CTMS
  • Infermed MACRO
  • Covance LabLink
  • Roche Diagnostics WinCAEv
  • Perceptive Informatics ClinPhone
  • Veeva Vault
  • Bracket IWRS
  • PPD Preclarus
  • CluePoints
  • IQVIA Infosario
  • Endpoint IRT
  • Medrio

Clinical Research Therapeutic Areas

  • Rare Disease: Hematopoietic Stem Cell Transplantation Associated Thrombotic Microangiopathy (HSCT-TMA)
  • Infectious Disease: HIV; Cytomegalovirus (CMV); Toxoplasmosis; Herpes
  • Women’s Health: Vitamin D
  • Cardiovascular: Atrial Fibrillation; Acute Coronary Syndrome; Congenital Heart Defect
  • Surgical Vision
  • Medical Device

Ich Gcp Training

CITI GCP for Clinical Trials with Investigational Drugs and medical Devices (US FDA Focus)

Affiliations

  • o Association of Clinical Research Professional
  • o Association for Women in Science

Certification

IUPUI Continuing Education Clinical Research Certificate

Languages

English
Native or Bilingual

Timeline

Vice President, Consulting Service

CluePoints
10.2022 - 12.2024

Central Monitoring Consultant

CluePoints
01.2022 - 09.2022

Associate Director, Study Lead Country Operations

Alexion AstraZeneca Rare Disease
11.2020 - 01.2022

Associate Director, Risk Management and Central Monitoring

Janssen Pharmaceutical Companies of Johnson & Johnson
09.2018 - 11.2020

Manager, Risk Management and Central Monitoring

Janssen Pharmaceutical Companies of Johnson & Johnson
09.2017 - 09.2018

Senior Specialist, Risk Management and Central Monitoring

Janssen Pharmaceutical Companies of Johnson & Johnson
01.2016 - 09.2017

Central Monitoring Specialist

DOCS Global for Janssen Pharmaceuticals
04.2015 - 01.2016

Manager, Study Monitoring

Roche Diagnostics Corporation
10.2011 - 03.2015

Senior Data Coordinator

Roche Diagnostics Corporation
10.2007 - 09.2011

Clinical Research Associate

Roche Diagnostics Corporation
10.2001 - 10.2007

Research Scientist

Roche Diagnostics Corporation
01.1991 - 09.2001

Scientist 1

Roche Diagnostics Corporation
01.1989 - 01.1991

Associate Chemist

Becton Dickinson Diagnostic Instrument Systems
08.1988 - 11.1988

Research and Development Chemist

Quad Pharmaceuticals
10.1987 - 07.1988

Lab Technician

Cargill Corn Milling Division, Fructose Lab
02.1987 - 10.1987

Bachelor of Science - Chemistry

Indiana State University

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Jennifer Bournique