Janet A.

Experience

1. Lead Clinical Data Manager

   Rho

   Jun 2023 — Present

   Provide DM functional support to help deliver quality and timely data in a manner that enhances the integrity, speed, and outcomes of the trial. •Manage cross-functional communication between data management, biostatistics, programming, and clinical operations, ensuring alignment on timelines. •Serve as primary data management contact in sponsor interactions, proving expert input on data integrity, query trends, and submission readiness•Partner with project management to develop realistic timelines, ensuring critical data management milestones were met or exceeded •Lead end to end data management activities for global phase clinical trials across multiple therapeutic areas, ensuring timely database lock and regulatory submission readiness. •Oversee design of eCRFs, edit check specifications, and UAT processes, improving data quality and reducing post database lock queries. •Help in creation and implementation of data management plans (DMPs), data entry guidelines, data completion guidelines and other study documents. •Collaborated with quality assurance teams to support audit and inspection readiness, successfully navigating multiple sponsor and regulatory audit with zero critical findings.•Manage electronic data capture (EDC) system design, development, testing, and validation, including oversight of all database specifications (eCRF, SDTM where applicable, edit check, external transfer, randomization, etc.). •Directed vendor oversight activities, including EDC build reviews, data transfer specifications, and reconciliation processes, resulting in 100% on time deliverables. •Coordinated database migration activities to support ongoing and long-term trials. •Follow-up with the project team to answer questions, to ensure data timeliness and cleanliness, and to process and follow queries to closure. •Led post-study data archival activities and collaborated with regulatory teams to prepare data packages for FDA/EMA submissions.

Education

• Igbinedion University, Okada

  Bachelor of Applied Science - BASc