Michelle Mateleska

Developed and executed UAT scripts for Spectrum, Veeva eTMF, CTMS and SIP, improving system reliability by 15% and maintaining 100% regulatory compliance for validation documentation.

Managed CTMS data, provisioning, and UAT in ALM, reducing entry errors by 20%, training 50+ users to increase adoption by 30% and serving as backup lead to maintain team productivity.

Reviewed and cleaned CTMS data to achieve 98% accuracy, executed UAT and helpdesk processes resolving 95% of issues within SLA, and generated safety reports to improve reporting efficiency by 25%.

Supported oncology teams preparing FDA submission documents and audit-ready study e-rooms, improving document accessibility by 15% and ensuring timely metrics and meeting deliverables.

Supported global site directors and multiple departments in clinical data management, resolved Oracle data issues, and managed budgets and staffing activities, saving 10% in operational costs.

Provided administrative support to Clinical Data Management, processed expense reports, maintained training records and onboarding documentation, and tracked staff leave and departmental projects.

Managed ClinTrial database entries, CRF listings and audit logs, maintained master file documentation and supported regulatory submission preparation to ensure compliance and data integrity.

Performed accurate data entry, managed billing and cash applications, maintained vendor contracts and payroll timesheets, and generated monthly reports using Microsoft Access to support operations.

Composed professional correspondence, processed expense reports, arranged travel and maintained calendars and mail handling to ensure efficient administrative operations.

Performed phlebotomy across patient populations, supervised scheduling and specimen tracking, and accurately entered patient test results to support laboratory operations over a 12-year tenure.

Completed a certificate program in phlebotomy with coursework including algebra, sociology, and psychiatry.