Nikki Francine B.

Experience

• 

  Novartis

  Oct 2016 - Dec 2016

  Clinical Research Intern
• 

  IQVIA

  Sept 2017 - May 2019

  Acted as the main liaison between the sponsor and the sites during the trial start-up phase.Performed budget negotiations.Finalized the contract language based on the sponsor’s and the institution’s requirements.Obtained Regulatory Authority approval and Ethics Committee approval for the entire study.Ensured overall project efficiency and adherence to project timelines.Obtained import licenses for the investigational products and laboratory kits.Obtained export licenses for biological samples.Prepared the Essential Documents Pack.Main proponent of IQVIA’s RECoRD: Research Ethics Committee Requirements Database which lists down the technical, financial, and documentary requirements of the various Philippine sites. Show less

  • Regulatory and Start-Up Specialist I

    Oct 2017 - May 2019

  • Clinical Research Associate Trainee

    Sept 2017 - Oct 2017
• 

  Syneos Health (Previously INC Research/inVentiv Health)

  May 2019 - Jun 2021

  Site Start-Up and Regulatory Specialist II

  Had set up all the regulatory, technical, and ethical requirements needed to initiate the clinical trial sites within the forecasted approval timelines.Handled the start-up activities of over 20 multi-center clinical trials.Prepared and facilitated the execution of Clinical Trial Agreements.Negotiated the financial aspects of the project with the sites.Actively provided solutions to improve start-up processes and timelines.

• 

  Parexel

  Jun 2021 - Mar 2023

  Site Contract Leader

  Negotiated Clinical Site Agreements for Australia, New Zealand, Philippines, and South Africa.Acted as a functional leader on projects and developed the study-specific Clinical Site Agreement (CSA) strategy.Drafted legal language and created budgets for CSA negotiations.Negotiated study-specific CSA templates with the Sponsor and the sites.Communicated the CSA strategy, turnaround timelines, and budget requirements with key stakeholders.Defined a solution strategy for significant CSA changes requested by the site. Show less

• 

  Fortrea

  Mar 2023 - Mar 2025

  Sets up clinical trials in Malaysia, Philippines, and Singapore.

  • Assoc. Project Manager, Start Up

    Apr 2024 - Mar 2025

  • Clinical Operations Manager supporting MSD

    Mar 2023 - Apr 2024