Jay Cochran

Project Manager, PMO & Clinical Operations at Vaxart, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Houston
Languages
  • English Native or bilingual proficiency
  • Spanish Full professional proficiency
  • French Limited working proficiency
Skills

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Bio

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Credentials

  • ACRP-CP
    Association of Clinical Research Professionals
    Apr, 2019
    - Nov, 2024

Experience

  • Vaxart, Inc.
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Project Manager, PMO & Clinical Operations
      • Nov 2021 - Present

      • Anticipate concerns and issues in the project and develop risk assessments and contingency plans • Primary source of communication for the project team to discuss and align milestone dates • Tracking and forecasting of budgets, monthly accruals, metrics and timelines for all project deliverables • Responsible for timely execution of change orders to ensure that the project margins are being met. • Support overall operational execution of global clinical studies from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.). Show less

  • 23andMe
    • United States
    • Biotechnology Research
    • 400 - 500 Employee
    • Project Manager, Clinical Development
      • Dec 2022 - Present

      • Lead and manage clinical research projects from initiation to closeout, ensuring adherence to timelines, budgets, and quality standards. • Oversee project budgets, monitor expenses, and implement cost-saving measures to meet financial objectives. • Manage relationships with third-party vendors, such as contract research organizations (CROs) and central laboratories, to ensure their performance aligns with project goals. • Maintained high-quality standards throughout the project, including the implementation of SOPs and GCP guidelines. • Support overall operational execution of global clinical studies from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.). Show less

  • Self-employed
    • Study Start-Up Manager (Consultant)
      • May 2021 - Nov 2021

      • Demonstrated expertise in regulatory requirements and processes, ensuring the timely submission and approval of clinical trial applications, ethics committee approvals, and other essential documents. • Managed contract negotiations with investigative sites, vendors, and sponsors, optimizing budget allocation and ensuring compliance with study requirements. • Collaborated with cross-functional teams, including clinical operations, regulatory affairs, and project management, to streamline study start-up processes and facilitate efficient study initiation. • Maintained accurate and organized study start-up documentation, including essential regulatory and site-specific documents, to support audit readiness and trial integrity. Show less

  • Labcorp Drug Development
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Operations Manager
      • May 2020 - Nov 2021

      • On assignment at Merck & Co.• Ensure projects delivered on time and budget, resolve operational issues, draft comprehensive reports, and implement long-term strategies in alignment with regulations. • Maintain quality in all activities, monitor project plans, participate in project meetings, and liaise with other departments to complete submissions. • Maintain full compliance with all regulations, standard operating procedures, and clinical procedures. • Work proactively to improve processes and establish refinements that reduce cycle time, create savings, and improve efficiency in the initiation of clinical trial sites.• Conducts thorough review of key specification documents related to the trial and oversees/participates in study plans, including Study Master Plan, Site Activation Plan, Site Monitoring Plan, TMF Plan, Site Contract and Budget Plan and Risk Management Plan.• Collaborate with vendor relationship leads to monitor vendor performance by identifying trends in escalated issues and ensuring adherence to established KPIs and quality standards.• Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget, and initiates change orders when necessary. Show less

    • Senior Specialist, Global Site Services
      • Jan 2015 - May 2020

      • Completed CRF review, query generation, and resolution; compared against established data guidelines to ensure accuracy. • Maintained full compliance with all regulations, standard operating procedures, and clinical procedures. • Escalated changes in contracts/budgets outside of fall-back parameters to appropriate point of escalation.• Negotiated CDAs and other agreements with sites during study feasibility.• Oversee all clinical specialists, contracts, budgets, and amendments for more than 150 sites.• Cultivate key relationships with sponsors, executives, colleagues, and industry professionals. • Deliver weekly presentations to sponsor with site activation progress. • Ensure projects delivered on time and budget, resolve operational issues, draft comprehensive reports, and implement long-term strategies in alignment with regulations. • Maintain quality in all activities, monitor project plans, participate in project meetings, and liaise with other departments to complete submissions.• Senior Specialist/Specialist II: March 2018 to May 2020; Specialist I: May 2016 to March 2018; Associate: January 2015 to May 2016 Show less

  • DOCS
    • Ireland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Contracts & Grants Analyst
      • Jul 2019 - Nov 2019

      • Led contract negotiations with investigative sites, vendors, and sponsors to secure favorable terms and ensure adherence to budget constraints, optimizing cost-effectiveness for clinical trials. • Developed and managed budgets for clinical trials, tracking expenses, forecasting costs, and implementing cost-saving strategies while maintaining financial compliance. • Cultivated and maintained strong relationships with vendors and stakeholders, overseeing vendor performance and ensuring timely delivery of services in alignment with contract terms. • Ensured that all contracts and budgets complied with regulatory and ethical standards, maintaining meticulous documentation for auditing purposes and contributing to the overall success and integrity of clinical trials. Show less

  • DISCOVERESEARCH, INC.
    • United States
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Clinical Research Coordinator
      • Sep 2013 - Oct 2014

      • Coordinated all aspects of clinical trials, including protocol compliance, subject selection, retention, follow-up, and documentation maintenance. • Served as Coordinator for phase III randomized, placebo-controlled, double-blind trial that evaluated the safety and efficacy of an investigational product alone and in combination with a marketed drug to treat acute influenza. • Led randomized, chronic dosing, double-blind, placebo-controlled, parallel group, multi-center study; analyzed safety and efficacy of investigational product with moderate to severe COPD. Show less

Education

  • Lamar University
    Master of Public Health - MPH
    2019 - 2021
  • Lamar University
    Bachelor of Arts (B.A.), Biochemistry
    2006 - 2011
  • Inter-American University of Puerto Rico - Metropolitan Campus
    MBA
    2023 - 2025
  • Universidad Politécnica de Puerto Rico
  • Angelina College
    Spanish Language and Literature
    2003 - 2005
  • Austin Community College
    Computer Science, Japanese
    2011 - 2013
  • Isla Grande FS
    2021 -

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