Project Manager - Data Entry Specialist
Resume:
Donna Odufeko
Dallas, TX (willing to relocate) Mobile: 469-***-**** ************.****@*****.*** SUMMARY
Project Manager with 8+ years of experience delivering multiple concurrent complex projects. Ensuring timelines, deliverables, quality standards, and organizational objectives are consistently achieved. Skilled in technical project coordination, stakeholder communication, risk mitigation, process improvement, resource management, and tracking key performance indicators (KPIs) to support strategic decision-making and operational success. With expertise in coordinating with multi-level operations. Recognized for strong organizational skills, attention to detail, problem- solving abilities, and the ability to manage multiple priorities efficiency, accountability, and deliver high-quality results while supporting team and organizational goals. CERTIFICATIONS & SKILLS
Certifications: PMP (In Progress), Good Clinical Practice (GCP) certified Project Management: Project Coordination, Schedule Management, Risk Mitigation, Stakeholder Communication, Resource Planning, Quality Assurance, Tracking KPIs, Study start up activities: Clinical Trial Agreement, Budget, IRB submission (draft and finalization), Problem Solving, Supply chain and Logistics, Site selection for clinical studies, Global studies and status follow up, Conflict Resolution. Tools: Microsoft Office, Power Bi, Project, Salesforce, Excel, EDC, CTMS, eTMF: Medidata Rave, Zelta, Oracle, Florence, Veeva Vault, IMPACT., EPRO, patient diary •IRT/IVRS/IWRS: Calyx, Clinphone, Drug data review and verification: Vestigo., • Central Lab Vendors: LabCorp and Beckman C., Central IRB: Advarra and WGC.,• EMR: EPIC, eClinical and Allscripts., • eSource: CRIO, • MS Office: Excel, Word, PowerPoint, One Note, Teams, Outlook., • Google Workspace: Calendar, Documentation, Meeting, Screencast, Gemini and Gmail., • Data Visualization platform: Power BI and Miro. •SharePoint folders: Complion, Florence, BOX, Institution’s specific SharePoint folder., OneDrive and Dropbox., AI: Chat GPT, Copilot and Gemini., Clinical Software Meeting: MS Teams, Zoom, Webex, and Google Meet., •Other systems: Docusign, SignNow, Adobe Acrobat, Slack, SaaS, SQL and Python
Core Strengths: Organizational, Time management, Attentive, Reporting & Documentation, Data Entry & Review, Analytical thinking, Attention to Detail, Quality Assurance, Training, Process Improvement, Cross-Functional Collaboration
EDUCATION
University of North Texas Denton, TX
Bachelor of Science in Health Promotion, Graduated 2013 WORK EXPERIENCE
MedaSource Agency - Abbott Laboratories
Clinical Site Lead (3-month part time contract).
May 2025 - August 2025
• Ensured day-to-day coordination of multiple project sites in line with company SOPs, confirming deadlines, documentation, and quality standards.
• Improved stakeholder communication and issue resolution by serving as a primary point of contact for cross- functional teams and addressing inquiries in a timely manner.
• Identified operational gaps and implemented corrective actions to improve workflow efficiency. Page 2 of 3
• Confirmed all regulatory documents followed by ALCOAC+ principles, IRB standards, and FDA regulations. Ensuring proper storage.
Beckman Coulter
Operations Manager
June 2024 - April 2025
• Ensured study start up initiatives were completed within the appropriate time frame.
• Supported daily operations and improved workflow efficiency by coordinating schedules, documentation, and communication across cross-functional teams and stakeholders.
• Increased operational readiness by assisting with onboarding activities, reviewing and confirming data for multiple sites. This includes administrative and supporting documentation.
• Maintain 95%+ accuracy in a fast-paced environment by managing multiple priorities while ensuring strong attention to detail.
• Enhanced team collaboration and operational effectiveness by partnering with cross-functional teams to resolve issues and identify workflow improvements. ProSciento
Senior Project Manager Coordinator
August 2023- April 2024
Facilitated weekly meetings with sites, provided status updates, and communicated progress to leadership.
Strengthen project execution and stakeholder alignment by maintaining ongoing communication with internal teams and external partners.
Created tracking tools to monitor progress, risks, and deliverables at sites. Also, maintained study trackers notating any vital site updates.
Supported study start-up through close-out, managed timelines, and served as a primary coordination point.
Ensured accurate and timely AE/SAE reporting in compliance with regulatory timelines and SOPs.
Managed multiple concurrent projects, re-prioritizing assignments based on study needs to meet strict deadlines and quality
AstraZeneca
Lead Operations Specialist/ Lead Clinical Research Associate Apr2017-May2023
Led long-term, multi-site projects from initiation through close-out.
Worked with global colleagues to ensure US drug inventory and management was within compliance and accounted for.
Improved project organization and supported 95% on-time deliverables by coordinating operational activities and providing cross-functional team support.
Prior experience working with VA hospitals, ensuring proper procedures were completed per the site’s SOP and Sponsor study guidelines.
Worked closely with the supply chain to ensure proper inventory of drug (IP) and confirm accurate location of drug shipment to site. Also ensuring accurate inventory forecasting of IP inventory during holidays.
Facilitated monthly local team meetings and global meetings to provide study updates regarding study metrics, risks, trends, and process improvements.
Increased productivity and operational efficiency by supporting issue resolution and coordinating processes to minimize workflow disruptions
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Enhanced documentation of accuracy and consistency by confirming IRB submissions, amendments, interim analyses, and database locks, ensuring 100% compliance with GCP and sponsor requirements.
Verified regulatory documentation, IRB coordination, drug accountability, completed 100% SDV and SDR, and ISF/eTMF maintenance.
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