Nayeli Diana Ibarra Arias

• Coordinate import/export of clinical study supplies including IMPs, medical devices, and laboratory equipment across multiple countries

• Prepare and submit regulatory license applications, amendments, and renewals to competent authorities

• Manage customs clearance processes and liaise with brokers, couriers, and regulatory bodies • Oversee depot operations including inventory management, distribution, and quality issue resolution

• Serve as point of contact for logistics audits and customer import/export inquiries.

• Supported Global Study Managers in trial operations across therapeutic areas, managing study tracking and CTMS updates

• Maintained study documentation and coordinated communications for cross-functional teams

• Key Achievements:

SME for Veeva Vault TMF System and Computerized System List; mentored junior staff; managed 500+ document submissions

• Coordinated CRA training logistics and investigator meetings, managed vendor relationships and system access controls

• Led processing of essential clinical trial documents ensuring regulatory compliance and inspection readiness

• Provided training and mentoring to new Records Management Specialists

• Conducted quality control reviews and audit support activities

• Key Achievement:

Implemented quality improvement training programs and error reconciliation processes

• Processed clinical trial documents for study startup, drug shipment, and eTMF maintenance

• Indexed documents in Veeva Vault with required metadata and performed peer reviews

• Maintained document processing metrics and coordinated communications across functional areas

• Key Achievement:

Served as main contact for TMF document process coordination.

Provided administrative support for clinical trial execution in accordance with ICH-GCP standards

• Managed ICF tracking, document filing, and TMF reconciliation with quality parameters

• Conducted quality control on quarterly reports per client requirements

• Key Achievements:

SME for Veeva Vault Clinical and Reconsent Oversight; developed and maintained training materials for new hires.