David Okonofua

Experience

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  Vytronus, Inc.

  Jul 2016 - Dec 2019

  Clinical Data Manager I

  • Maintained data entry guidelines and procedures.• Collaborated with the study team to develop a comprehensive Data Management Plan (DMP)• Ensured data integrity and adherence to data standards.• Audited charts to ensure integrity and quality clinical data and HIPAA compliance.• Developed and provided input for key clinical data management deliverables, which included: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines and data management plans• Ensured the development and design of data collection forms were in accordance with study protocol and established standards.• Monitored the overall study progress daily, weekly, and proactively developed or adjusted plans as needed to achieve targets. Show less

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  Vertis Biotechnologie AG

  Feb 2019 - Dec 2022

  Lead Clinical Data Manager

  • Acted as the primary point of contact for data management projects.• Conducted teleconferences and led project status meetings with the project manager and clinical team.• Responsible for managing electronic file transfers between external vendors• Ensured timely cleaning of data in accordance with data review plan across projects• Provided input and oversight in study planning and execution by contributing to the following activities: protocol review, case report form (CRF) design, database design, CRF completion guidelines preparation, CRF annotation, data management plan (DMP) development, database coding, transfer and edit check specifications review, user acceptance testing (UAT) of electronic data capture (EDC) and interactive voice response systems (IVRS), ePRO specification creation among others.• Ensured that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.• Participated in Standard Operating Procedures update that aligned with and addressed business priorities.• Ensured project documents were filed correctly in study eTMF per company Standard Operating Procedures (SOPs). Show less

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  Army National Guard

  Sept 2019 - now

  Commissioned Officer (First Lieutenant)

  • Implements the Commander’s intent for the company.• Manages & supervises enlisted personnel assigned to my platoon.• Responsible for unit readiness within my platoon.• Plan, organize, and lead troops and activities in military operations.

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  CTI Clinical Trials and Consulting Services, Inc.

  Jan 2023 - now

  Lead Clinical Data Manager

  • Collaborates with the cross-functional team to perform end-to-end clinical data management activities from start-up to database lock for multiple studies.• Creates relevant data management documents for different stages of clinical trials, including but not limited to the Case Report Form (CRF), Data Management Plan (DMP), eCRF Completion Guidelines (CCG), Data Review Plan, Data Transfer Specifications (DTS), and Data Validation Specification (DVS).• Performs User Acceptance Testing (UAT) including validating data entry screens and testing edit checks.• Performs Vendor Reconciliation of Central Lab Data, ECGs, X-Rays & SAEs.• Performs ongoing data review throughout the study conduct, involving the identification, querying and resolution of discrepancies.• Identified inconsistencies and inefficiencies in data management process and recommended solutions• Created SOPs aligning data management with business priorities and compliance.• Mentors and supervises Clinical Data Associates (CDAs) as needed to perform various clinical data management activities. Show less