Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Ryan Ntawigenga

MIAMI,FL

Summary

Senior Clinical Biomarker Project Manager with 12+ years of experience in the pharmaceutical industry. Expert on clinical sample logistics planning and coordination from site to central lab and analytical lab.

Proven a track record of successfully leading cross-functional teams in Translational Medicine managing complex clinical studies from startup to publication. Strong track record of managing budgets, and external vendors, and samples management from shipment and testing to final data validation. Skilled in stakeholder management and the ability to effectively communicate results to both technical and non-technical audiences.

Overview

12
12
years of professional experience

Work History

Global Clinical Biomarker and Diagnostics Operations Lead

Amgen
Thousand Oaks, CA
10.2021 - Current
  • Leading translation Medecine team to ensure operational processes and procedures are followed efficiently and effectively.
  • Conduct site data review, including queries and protocol deviations
  • Responsible for study setup and management of TMF vendors
  • Drives the implementation of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas
  • Development of a project and/or clinical study biomarker and diagnostics biosamples strategy
  • Project management and appropriate forecasting and planning of related biomarker analysis and samples management costs within a project(s) or clinical studies
  • Develops a sample reconciliation plan for each sample type including data management for relevant data collection and reporting within studies while also ensuring consistency of reconciliation activities within project(s)
  • Reviews study protocols and sample collection ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the Biomarker and Diagnostics plans
  • Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/ data results and is a key contact for the assay lab.
  • Manage over $85M study budget.

Biomarker Operations Specialist/Biobank Ops Lead

Eisai Pharmaceuticals
Cambridge, MA
11.2020 - 10.2021
  • Translation research Operations Manager
  • Select and Processed specimens for clinical trials, sample storage and assay to provide registry of samples for test development, validation and analysis
  • Manage third party CRO/ vendors including timelines, sample and budgets
  • Led CDx Partners and managed multiple Companion Diagnostics Projects with Diagnostic Partners
  • Generated & submitted detailed reports to regulatory agencies & company leadership to drive enhancements
  • Execute US strategic objectives and project plans and milestones
  • Involved in clinical testing of Biomarkers
  • Coordinating and performing sample reconciliations and preclinical development
  • Plan and manage yearly budget plus a daily report
  • Actively do Data transfer and reconciliations
  • Developed and maintained an efficient process for tracking inventory levels, ensuring accuracy of data.
  • Conducted regular reviews of operational procedures to ensure compliance with company standards.
  • Monitored performance metrics and tracked progress against goals to identify opportunities for improvement.
  • Developed reports detailing operational performance, trends, costs, productivity.

Global Clinical Project Manager

LanceSoft
Boston, MA
11.2014 - 11.2020
  • Samples management and reconciliations
  • Compiled data from various sources into meaningful reports; analyzed results obtained from clinical studies; provided recommendations based on findings reported therein.
  • Managed resources efficiently across multiple project teams ensuring delivery according to quality standards set forth by clients.
  • Led clinical study operations include contracts.
  • Review lab manual and protocol amendments
  • Forecast studies budget
  • Manage and over CROs include clinical samples from global clinical trials
  • Receive and review data to incuse not discrepancy
  • Organized and led cross-functional teams to manage the development, execution, and reporting of clinical studies.
  • Generated timelines for protocol development, database lock, submission filing activities, and other milestones.
  • Negotiated contracts with vendors regarding cost estimates and service levels required for successful execution of studies.

Global Clinical Trial Manager

Dr. Pelagie Clincal Center
Kinshasa/Remote, DRC
09.2012 - 11.2014
  • Oversight of study start-up, study management, data cleaning, and study closeout activities
  • Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
  • Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.
  • Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
  • Develop timelines and budgets for assigned studies/programs and responsible for delivery to both quality and agreed timelines.
  • Project leadership of the cross-functional study team, including external team members, CROs and vendors.
  • Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
  • Provide technical advice to team members for risk mitigation.
  • Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
  • Interact with clinical research investigators, Key Opinion Leaders and sites.
  • Interact with Senior Management to report on progress of milestones.
  • Oversight of study team and site training
  • Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
  • Management of study drug distribution and accountability processes and documentation
  • Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival.

Education

Bachelor of Science - Biology

University of Massachusetts

Skills

  • Translation research operations expert
  • Oversight and TMF management
  • Overseeing CROs/external vendors
  • Overseeing the Global Biomarker strategy plan
  • Project Management
  • Data management and reconciliation
  • Protocol and Lab manual review
  • Coordinate Clinical trial
  • Data Transfer Management
  • ICF review and reconciliation
  • Samples reconciliations expert
  • Manage study budget ($85M)
  • Laboratory Information Management System (LIMS)
  • External Vendors evaluation expert
  • Microsoft Project, Word, Excel, PowerPoint, Outlook, Adobe Acrobat an SAP, SmartSheet, Veeva

Accomplishments

  • Co-finder of Clinical Biomarker Diagnostics Team (CBDT)

Timeline

Global Clinical Biomarker and Diagnostics Operations Lead

Amgen
10.2021 - Current

Biomarker Operations Specialist/Biobank Ops Lead

Eisai Pharmaceuticals
11.2020 - 10.2021

Global Clinical Project Manager

LanceSoft
11.2014 - 11.2020

Global Clinical Trial Manager

Dr. Pelagie Clincal Center
09.2012 - 11.2014

Bachelor of Science - Biology

University of Massachusetts

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Ryan Ntawigenga