At iSWERK | Talosix, I lead data management across multiple studies, from Data Management Plans and database design to edit checks and change control. I also lead database lock activities, including interim locks and controlled unlocks.
I drive query management, protocol deviation reconciliation, and SAE reconciliation with Pharmacovigilance. I review incoming data for trends, outliers, and risk signals, and prepare data and reports for statistical analysis and regulatory submissions.
As a Clinical Data Coordinator at iSWERK | Talosix, I abstracted and validated clinical data from medical records into EDC and performed User Acceptance Testing on new registries and platforms. I also maintained TMF documents in an accurate, current, and audit-ready state.
Earlier, I monitored Phase 2-3 studies at Tigermed Services Philippines Inc., conducting site visits and source data review, and supporting site follow-up, recruitment tracking, and regulatory submissions. My clinical trial experience spans areas including oncology, vaccines, cardiovascular disease, dermatology, and NASH/MASH.
