Summary
Overview
Work History
Education
Skills
Personal Information
Additionalworkexperience
Timeline
Generic

Vicki Duvall

Fort Worth,TX

Summary

Experienced leader skilled in optimizing resources, driving productivity, and achieving organizational objectives. Offers valuable insights into clinical strategy and planning, and effectively manages processes and resources through cross-functional collaboration. Committed to problem-solving and driving positive change through proven project management methodologies.

Overview

19
19
years of professional experience

Work History

Clinical Research Consultant

Croft & Ellis Consulting, LLC
01.2006 - Current
  • Collaborate on the development of study designs and comprehensive clinical protocols that adhere to regulatory guidelines.
  • Design, construct and implement research proposals, protocols and procedures.
  • Manage vendor relationships for effective collaboration on outsourced aspects of clinical research projects, ensuring cost-effective use of resources.
  • Collaborate with cross-functional teams to ensure seamless execution of clinical studies, resulting in successful project completion.
  • Provide expert guidance to junior team members on best practices in clinical research, contributing to their professional development and growth within the organization.
  • Improve clinical trial efficiency by developing and implementing streamlined processes for data collection and analysis.
  • Identify areas for improvement in existing processes through robust audits, leading to increased operational efficiency in subsequent studies.
  • Gather and evaluate quality assurance data to identify issues and improve process efficiency.
  • Review data and monitoring reports to identify trends or discrepancies, enabling informed decision-making during the course of a trial.

Senior Director, Clinical Operations

Vir Biotechnology, Inc.
08.2021 - 05.2023
  • Responsible for operational strategy and execution of clinical trials conducted in the Respiratory program.
  • Managed a cross functional team to achieve overall goals and improve performance of the portfolio.
  • Partnered with the Program Executive (PE) and Clinical Directors to ensure timely completion of clinical trials.
  • Defined clear timelines and objectives; accountable for translating the clinical development plan into an operational strategy.
  • Maintained operational budgets and timelines.
  • Communicated program status, costs, and issues to the executive management team.
  • Assisted in the development of quality Phase 1-3 study protocols and other study related materials.
  • Led Request for Proposals (RFP) to identify and select new CRO partners and worked with Procurement, QA, and Legal to qualify new vendor(s).
  • Provided input and approved all operational study plans including enrolment models and risk management strategies.
  • Implemented cost-saving measures through effective resource allocation and budget management.
  • Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
  • Established team priorities, maintained schedules and monitored performance.
  • Evaluated employee performance and conveyed constructive feedback to improve skills.
  • Collaborated with internal staff and external strategic partners/vendors on maintaining inspection ready status.

Vice President, Quality and Compliance

Trevi Therapeutics, Inc.
11.2020 - 06.2021
  • Collaborated with senior management to develop strategic initiatives and long term goals for QAC.
  • Implemented robust internal controls systems coupled with proactive monitoring mechanisms to ensure compliance.
  • Leveraged technology to automate workflows and streamline processes, resulting in increased productivity and improved compliance across the company.
  • Built and managed high-performance QAC team focused on overall quality and company wide compliance processes.
  • Managed financial planning and budgeting processes ensuring fiscal responsibility and maximizing return.
  • Collaborated with legal, accounting and cross functional teams to review and maintain compliance with regulations.
  • Communicated quality and compliance performance, forecasts and strategies to board of directors.

Sr. Director, Head of Clinical Operations

Trevi Therapeutics, Inc.
10.2018 - 11.2020
  • Provided operational leadership and management of clinical operations department with a primary focus on development and execution of rare disease trials (dermatology).
  • Executed business transformation initiatives by expanding early phase portfolio to drive growth opportunities.
  • Ensured successful execution of all clinical trials, from planning through development of CSR, according to company objectives and timelines.
  • Minimized company risk by ensuring study activities were conducted in compliance with ICH/GCP guidelines and applicable regulations.
  • Led multiple RFP processes to identify CRO/CRU partners for Phase I-IV trials; provided ongoing oversight of all external vendors collaborating on clinical trials.
  • Implemented cost-saving measures through effective resource allocation and budget management.
  • Provided strategic direction to study staff regarding company objectives, project timelines and deliverables.
  • Built a dynamic operational team expanding global director positions by 2 and increasing internal ops team by 5 FTEs.

Sr Director, Site Management & Clinical Monitoring

Trevi Therapeutics, Inc.
05.2015 - 10.2018
  • Managed global sites, clinical monitoring, and external vendors, in compliance with industry regulations.
  • Achieved program objectives and deliverables within the established timelines and budgets.
  • Managed budgetary requirements efficiently prioritizing resources allocation based on project needs while minimizing costs.
  • Conducted thorough assessments of monitoring activities, identifying areas for improvement and cost savings opportunities.
  • Developed comprehensive documentation of the Sponsor's oversight of monitoring processes, resulting in increased transparency and accountability.
  • Reviewed monitoring reports to identify trends and recommend preventative measures to prevent future issues.
  • Collaborated with stakeholders to identify potential risks and develop mitigation strategies.
  • Leveraged on-site observation and co-monitoring visits to identify and mitigate site and/or vendor issues.
  • Cultivated and strengthened lasting site relationships using strong issue resolution and dynamic communication skills.

Clinical Operations Lead

Trevi Therapeutics, Inc.
04.2014 - 05.2015


  • Led project teams through all phases of study implementation, from initial planning to final execution, ensuring successful completion within defined timelines.
  • Managed daily operations, ensuring timely delivery of high-quality data, adhering to project timelines and budgets.
  • Ensured strict compliance with industry regulations, maintaining up-to-date knowledge of relevant guidelines and best clinical practices.
  • Streamlined study operations by implementing efficient processes and optimizing workflows.
  • Created and managed project plans, timelines and budgets.
  • Collaborated with cross-functional teams to achieve company-wide objectives and drive operational excellence.
  • Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
  • Evaluated vendor staff performance and provided coaching to address inefficiencies.
  • Maintained database systems to track and analyze operational data.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Oversaw problem resolution to address barriers to operational and study efficiency and generated reports detailing findings and recommendations.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of operational decision-making.
  • Assisted in the development of long-term strategic plans, aligning operational goals with overarching company objectives.


Principal Research Associate

Medtronic
04.2012 - 04.2014


  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
  • Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
  • Conducted meetings with sponsor representatives to discuss clinical study developments and effectively resolve study-related issues.
  • Leveraged GCP knowledge, expertise and problem-solving techniques to resolve investigative site issues.
  • Produced monitoring reports and follow-up letters to facilitate internal and external communication.

Senior Clinical Research Associate

PPD
10.2011 - 04.2012
  • Conducted clinical monitoring in compliance with GCPs and global SOPs to assess the safety of investigational products and medical devices.
  • Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
  • Performed site initiation, monitoring and closeout visits to verify subject safety, protocol compliance, study procedures, regulatory documents, and data completion.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
  • Reviewed participant eligibility and consent documentation to ensure accurate and meaningful results were achieved.
  • Communicated project status to project management team and monitoring manager verbally and through monitoring documentation.
  • Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
  • Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
  • Managed project risk by identifying, quantifying and monitoring potential site issues.
  • Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.

Senior Director, Clinical Trials Office

Dana-Farber Cancer Institute
08.2008 - 09.2011
  • Developed and implemented initial Clinical Trials Office (CTO) infrastructure offering centralized services, specialized expertise, and administrative oversight of all clinical research activities.
  • Achieved overall institutional goals by developing and implementing strategic plans and initiatives.
  • Developed strong relationships with key industry partners, fostering collaboration and mutual growth opportunities.
  • Revitalized institutional policies and procedures to conduct clinical research under a standardized model.
  • Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.
  • Established data-driven decision-making processes and implemented best practices in analytics to optimize performance across the organization.
  • Instituted formal operating procedures and enforced adherence to policies and regulations that impacted the bottom-line.
  • Drove strategic improvements to enhance operational and organizational efficiencies.
  • Successfully managed budgets and allocated resources to maximize productivity and profitability.
  • Led cross-functional teams to successfully launch new studies, meet project deadlines and adhere to budgets.
  • Grew talent pool by actively recruiting top-tier candidates from diverse backgrounds while implementing robust training programs for skill development across all levels of staff members.
  • Evaluated employee performance and conveyed constructive feedback to improve skills.

Education

Bachelor of Science - Nursing

George Mason University
Fairfax, VA

Skills

  • Strategic Planning
  • Clinical Trial Management
  • Virtual Project Teams
  • Vendor Management
  • Good clinical practice
  • Regulatory Compliance
  • Problem-solving
  • Relationship Building
  • Communication
  • Adverse event reporting
  • Site monitoring
  • Electronic data capture
  • Teamwork and collaboration
  • Informed consent process

Personal Information

Title: RN BSN

Additionalworkexperience

  • Director, Clinical Trials Office, Baylor Research Institute
  • Owner/Director, Texas Institute of Clinical Research
  • IRB Administrator, Texas Health Resources
  • Site Research Manager, Texas Health Care, LLC
  • Clinical Research Associate, Facilitators of Applied Clinical Trials
  • Clinical Research Associate, National Institutes of Health

Timeline

Senior Director, Clinical Operations

Vir Biotechnology, Inc.
08.2021 - 05.2023

Vice President, Quality and Compliance

Trevi Therapeutics, Inc.
11.2020 - 06.2021

Sr. Director, Head of Clinical Operations

Trevi Therapeutics, Inc.
10.2018 - 11.2020

Sr Director, Site Management & Clinical Monitoring

Trevi Therapeutics, Inc.
05.2015 - 10.2018

Clinical Operations Lead

Trevi Therapeutics, Inc.
04.2014 - 05.2015

Principal Research Associate

Medtronic
04.2012 - 04.2014

Senior Clinical Research Associate

PPD
10.2011 - 04.2012

Senior Director, Clinical Trials Office

Dana-Farber Cancer Institute
08.2008 - 09.2011

Clinical Research Consultant

Croft & Ellis Consulting, LLC
01.2006 - Current

Bachelor of Science - Nursing

George Mason University

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Vicki Duvall