Mady Odeyomi

About Mady Odeyomi

15+ years experienced professional, result-oriented Lead Clinical Data Manager with vast…

Experience

1. Senior Clinical Data Manager

   Edwards Lifesciences

   Oct 2022 — Present

   Lead Data manager for the Mitral valuve study, overseeing data reliability, intergrity and compliance withe regulatory standards for PMA submissions and associated publications/podium activities.Managed the data management activities for the ENCIRCLE EU MDR submission, supporting the updated CE Marking process and ensuring alignment with ISO 13485 requirements.Manage multiple project startups, migration releases, regulatory submissions (APR, PMA, MDR), including multi-site and multi-cohort studies.Lead interactions with senior leaders on significant matters and decisions impacting multiple functions.Lead Data manager for the new Aortic regurgitation and stenosis treatment studies, ensuring quality and integrity of data collected in the clinical studies, maintain patient data privacy, and efficiently recorded and reported safety-related issues.SME for database build, study set-up, migrations, database maintenance, lock and unlock, early site closure study closure and data analytics using Power BI, BO4 and visualization tools.Created complex metrics to identify data trends and remediation needs, utilizing visualization tools and reportsSpecified clinically complex data collection requirements, including eCRFs, edit checks, Completion guidelines and external data collectionMentor junior colleagues and new joiners on THV data management process and tools.Develop and maintain Data Management deliverables, including DMPs, eCCGs, DTS and other CDM documents.Delivered EDC user training to external Monitoring team and CRA partners.Proven ability to work effectively in team environments and self-motivated to deliver business value.Perform Site/User Administration to manage database access and provided guidance on complex issues.Exceptional written and verbal communication skills, with strong interpersonal abilities, including negotiation and relationship management.Received numerous special recognitions for excellent delivery and problem-solving skills.

Education

• University of Houston

  Master of Business Administration - MBA, Strategic Management

• Northcentral University

  Doctor of Arts, Business Administration and Management, General

• National University

  Doctor's Degree