Eniola Owoyomi

About Eniola Owoyomi

Clinical Data Management professional with 10+ years of experience across sponsor and CRO environments, managing global trials from start-up through database lock and regulatory submission. Most recently at Moderna, I led eTMF oversight and document migration from CRO Veeva Vault to Moderna\'s Veeva Vault, ensuring GxP compliance and inspection readiness for FDA and PMDA submissions. My background spans the full DM lifecycle — protocol review, eCRF/EDC build, UAT, SAE reconciliation, vendor oversight, and database lock — across oncology, cardiovascular, CNS, and infectious disease trials. I bring hands-on expertise in Medidata Rave, Veeva Vault, IBM Clinical, and Medrio, with strong command of CDISC, SDTM, and CDASH standards and regulatory frameworks including ICH-GCP, FDA, and 21 CFR Part 11. Whether in a lead CDM, eTMF consultant, or data governance role, I\'m known for driving cross-functional alignment, mentoring junior staff, and delivering clean, audit-ready data under tight timelines. Open to full-time and contract opportunities — on-site (Texas), hybrid, or remote. e••••••••@gmail.com Therapeutic Experience: Oncology, Medical Devices, Cardiovascular, Respiratory, Infectious Disease (Hepatitis C) and Central Nervous System (CNS).

Experience

1. Senior Clinical Data Manager (Tmf Consultant)

   Moderna

   Aug 2022 — Present · US

   QC and oversight of section 10 (Data Management) of the TMF and ensure all appropriate documents are filed. Responsible for Efficient and appropriate management of Trial Master Files (TMF) and other TMF related, inspecting relevant documents from creation through archival in compliance with applicable SOP’s, processes and study specific requirements for clinical trials. Responsible for migration from CRO’s Veeva Vault to Moderna Veeva Vault and review after migration for accuracy. Communicate and support TMF operations oversight of multiple CRO partners TMF activities - based in Veeva. Ensure quality, consistency, data integrity and completeness of documents relevant for 1st submission, 2nd submission, Designated and justification documents for inspection readiness such as FDA. PMDA, Internal mock inspection, etc. are accurate and uploaded in the inspection SharePoint within timeline. Ensure filed or uploaded documents which fail TMF quality content or TMF inspection readiness are QC for internal and external representative review for TMF compliance. Assist with change management during migration activities from CRO into the company environment. Attends and schedule meetings with CROs weekly and bi-weekly or as necessary. Promote the best documentation practice. Responsible for Storyboard per study assigned. Template includes production Acceptance form, migration/publish check, CCG version, Edit check programming etc. Coordinate inspections by ensuring Lists of expected documents from Data management are uploaded in SharePoint for inspection readiness Review TMF quality early and during the study, with targeted and risk-based approach. Identify & communicate gaps completeness and quality gaps throughout the studies. Ensure deliverables comply with guidelines, Good Clinical Practices. Responsible for definition of applicability and review number of expected documents in the eTMF systems, and TMF management/Index plan.

Education

• Lagos State University

  Bachelor's degree, Business Administration and Management, General