Teams at WEP Clinical

Provides operational and administrative support for Expanded Access Programs, including project setup, documentation, site communication, investigational product shipments, invoice filing, regulatory document review, eTMF maintenance, and CTMS data entry. Coordinates with project management, supply chain, finance, regulatory, sponsors, and clinical sites to support compliant program execution and client expectations.

Supports electronic Trial Master File setup, maintenance, quality checks, reporting, archival, and audit readiness. The role manages clinical study documentation, trackers, scanning, filing, document reviews, and compliance with SOPs, GCP, ICH guidelines, privacy standards, and sponsor requirements. It also coordinates document retrieval and finalization across stakeholders, assists with staff training, and performs proofreading and administrative tasks.

Lead on-site and remote clinical monitoring to ensure protocol, ICH-GCP, and regulatory compliance. Manage site selection, initiation, routine and close-out visits; verify source data and CRFs; review safety and IP accountability; resolve queries and drive CAPAs; train and mentor CRAs; act as primary monitoring contact for sponsors and project teams.