Enikő Czaga-Olbrychtowicz

Managed a GCP-compliant research site across multiple concurrent studies, coordinating feasibility, quality support, and TMF maintenance. Liaised with partner sites and global study teams on KPIs and process improvements.

Oversaw full operational management of a research site, including patient recruitment, visit scheduling, and resource capacity. Ensured GCP and protocol compliance through supervision and documentation review.

Provided regional quality and compliance oversight across three CEE countries, planning internal audits and coordinating sponsor audits and regulatory inspections. Led SOP and CAPA harmonisation and maintained a regional quality event tracker.

Managed operational compliance and quality across Hungarian clinical research sites, including SOP lifecycle, deviation management, and CAPA processes. Contributed to the implementation of a centralised QMS and ensured no critical findings in FDA or sponsor inspections.

Led data coordination across multiple trials, ensuring data integrity and eCRF quality. Performed source data verification and prepared for audits and monitoring visits, while training junior coordinators.

Performed data entry, review, and query resolution across concurrent trials, ensuring GCP compliance. Contributed to documentation preparation for monitoring visits, audits, and inspections.

Served as the first point of contact for the site, handling patient reception, appointment management, and document handling. Provided administrative support to clinical and operational teams.

Completed a Bachelor of Economics at Zsigmond Király University in Budapest.