Summary
Overview
Work History
Education
Skills
Timeline
Generic

Etaria Omekwe

Dallas

Summary

Highly Skilled and enthusiastic Clinical Project Manager with 7 years of experience in managing complex clinical trials and projects. Proven expertise in overseeing all aspects of project planning, execution, and delivery within strict timelines and budget constraints. Skilled in cross-functional team leadership, risk management, and regulatory compliance. Seeking a challenging position to drive the successful execution of clinical projects and contribute to the advancement of healthcare.

Overview

13
13
years of professional experience

Work History

Senior Clinical Trial Manager

Telavant Inc
11.2023 - 12.2023
  • Led and provided oversight over the startup activities associated with a phase 3 global study in Ulcerative Colitis. Tasks included leading study team through protocol development and finalization, CRO and vendor selection, feasibility and CDA processings, site and investigator engagement, budget and timeline forecasting and study and program specific strategic planning.


  • Telavant Inc was purchased by Roche, hence the termination of employment on December 31st 2023.

Sr. Clinical Operations Manager

Takeda Pharmaceuticals (Contractor)
06.2022 - 11.2023
  • Successfully managing multiple clinical projects from from phase 1-3, ensuring adherence to project scope, timelines, and budget.
  • Leads cross-functional project teams, including clinical operations, data management, biostatistics, and regulatory affairs, fostering collaboration and effective communication.
  • Developed comprehensive project plans, including timelines, milestones, and resource allocation, resulting in efficient project execution and on-time deliverables.
  • Conducted risk assessments and developed risk mitigation strategies to minimize project risks and ensure project success.
  • Monitors project progress, identified deviations from plan, and implemented corrective actions as necessary to keep projects on track.
  • Collaborates with vendors, contract research organizations (CROs), and other external partners to ensure adherence to project timelines, quality standards, and budget constraints.
  • Provides oversight over the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications and study protocols, in compliance with FDA and ICH-GCP guidelines.
  • Coordinates and manages project budgets, tracking expenses, and ensuring cost-effectiveness while maintaining quality and scope.
  • Conducts regular project status meetings, providing updates to stakeholders and addressing any concerns or issues.
  • Collaborates with medical writers and statisticians to ensure accurate and timely completion of clinical study reports and statistical analyses.


Clinical Project Manager

Epizyme Inc.
03.2021 - 05.2022
  • Ensured operational execution of clinical studies within required timelines and budget, and in accordance with regulatory requirements and Epizyme Standard Operating Procedures
  • Managed internal resources, external partners, consultants, vendors and external budgets to ensure the timely and cost-effective delivery of clinical studies for multiple global development programs
  • Coordinated and managed execution of key deliverables for clinical trials, including protocols, case report forms, statistical analysis plans, data management plans and clinical study reports
  • Established and maintained effective communication and collaboration with functional area peers, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing, as well as thought leaders to meet program objectives and support achievement of departmental and corporate goals
  • Provided leadership and supervision over vendor/CRO selection, contract and budget negotiation process, deliverables and trial milestones as appropriate
  • Oversaw the execution of study plans, protocol development, budget planning and maintenance of global studies ranging from early phase to phase 3


  • Provided support to Field Clinical Research Associates (CRAs) and assisted in the initiation, monitoring and coordinating day-to-day operations of clinical trial sites
  • Conducted monitoring visits including pre-study, initiation, interim monitoring and close out visits as needed.


Clinical Trial Manager

National Cancer Institute (Nova Research Company)
12.2017 - 03.2021
  • Provided strategic and managerial oversight for Biospecimen Collection and Global Early Phase Clinical Trial projects and subprojects
  • Duties included but were not limited to project planning, risk management, SOP, CRF and protocol development, site and vendor acquisition, site personnel training and biospecimen sample kit logistics
  • Effectively fostered communications between cross functional teams, logistical and/or requirements support for US and global sites
  • Creates project and specific timelines, budget tracking documents and recruitment reporting documents for leadership review
  • Performed grant management tasks which included tracking and updating grant status in electronic databases; responding to inquiries concerning grants management policies and procedures, status of individual awards, on a one-on-one basis
  • Provided data monitoring oversight of internal database system by identifying and analyzing data quality issues to initiate immediate corrective action plans and proactively contributed to risk assessment plans
  • Effectively maintained study budget, produced invoices and evaluated scope changes to address cost modifications throughout project lifecycle
  • Created study specific reports using excel spreadsheets and data visualization tools to deliver study metrics and updates to leadership and investigative sites
  • Conducted site feasibility assessments and qualification visits, and maintained oversight over team performance, expectations and project milestones.

Clinical Trial Associate

Landos BioPharma Inc. (Preferred Solutions Group)
01.2016 - 12.2017
  • Assisted with the oversight of multiple global trials ranging from early phase to phase 3; Duties included vendors and CRO communications, database oversight, strategic patient recruitment tasks, protocol and study document development, drug supply/depot coordination.
  • Facilitated communications between internal team members and investigative sites pertaining to activities such as study/collection start up, protocol training, equipment and data management issue resolution and/or escalation, and specimen shipping logistics
  • Monitored TMF for maintenance and completion, and resolved technical issues at the investigational/collection sites, maintained information and updated leadership and internal team members
  • Monitored and provided support of data entry to principal investigators, and study coordinators; collaborated with development teams to maintain clinical database
  • Analyzed project plan, identified the inefficiencies in existing processes and tracked performance following implementation of improvements
  • Successfully created site surveys and used resulting data to identify reasons for the poor accrual of specific specimen types and patient recruitment.

Repository Technician

NIH AIDS Reagent Program(Aerotek Contractor)
04.2015 - 12.2015
  • Successfully completed Inventory Reform project which included mapping out and
    accounting for every sample in the repository, formulating consolidation plans, creating
    new updated data sheets and reconciling discrepancies in database.
  • Created space equivalent to a large Nitrogen tank and saved the company the cost of
    purchasing a new tank.
  • Aliquotted biological samples.
  • Inventoried samples and checks applicable documentation to ensure accuracy and
    integrity of the inventory and/or shipments.
  • Handled distribution and inventory of frozen HIV-positive biological samples on dry ice
    and LN 2 .
  • Aliquoted bulk reagents/compounds and assemble reagent sets.
  • Updated ARPs inventory database as needed (ARMS, ScanIT)
  • Designed, Built and Updated spreadsheets programs to facilitate and track lab data
    entry.

Student Clinical Research Associate

Hampton University Proton Therapy Institute
01.2011 - 05.2013
  • Conducted monitoring visits to perform on site review of files and records for source document verification, and review of case report forms for completeness, accuracy and compliance
  • Performed drug accountability to ensure adequate storage, dispensing and use of investigational product
  • Assured timely and accurate completion of Data clarification forms
  • Assisted Clinical Project Manager on activities as related to study design, documents and processes
  • Assisted in developing specific CRA training guides, and other program development activities.

Education

M.Sc - Physiology and Biophysics

Georgetown University

Certificate - Advanced Biomedical Sciences

George Mason University

B.Sc - Biology

Hampton University

Skills

  • Clinical project planning and execution
  • Budgeting and resource allocation
  • Cross-functional team leadership
  • Risk assessment and mitigation
  • Regulatory compliance (FDA, ICH-GCP)
  • Vendor management and contract negotiation
  • Stakeholder engagement and communication
  • Quality control and assurance
  • Data analysis and reporting
  • Strong problem-solving and decision-making abilities
  • Excellent organizational and time management skills

Timeline

Senior Clinical Trial Manager

Telavant Inc
11.2023 - 12.2023

Sr. Clinical Operations Manager

Takeda Pharmaceuticals (Contractor)
06.2022 - 11.2023

Clinical Project Manager

Epizyme Inc.
03.2021 - 05.2022

Clinical Trial Manager

National Cancer Institute (Nova Research Company)
12.2017 - 03.2021

Clinical Trial Associate

Landos BioPharma Inc. (Preferred Solutions Group)
01.2016 - 12.2017

Repository Technician

NIH AIDS Reagent Program(Aerotek Contractor)
04.2015 - 12.2015

Student Clinical Research Associate

Hampton University Proton Therapy Institute
01.2011 - 05.2013

M.Sc - Physiology and Biophysics

Georgetown University

Certificate - Advanced Biomedical Sciences

George Mason University

B.Sc - Biology

Hampton University

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Etaria Omekwe