• Track, scan, code and send documents to the relevant study Work In Progress (WIP) area of PMED or send wet-ink documents to the respective Central Files office location as per the Central File Maintenance Plan (CFMP)
• Photocopy, print distributed and retrieval of documents as needed.
• Maintain basic quality check procedures to ensure accurate maintenance of documents.
• Tracking/ maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only)
• Organization of translations of study documents (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery)
• Support local site management team in the preparation of site-specific documents and cover letters
• Distribute study documents to sites and/or local authorities (e.g. via courier shipments) as required
• Assist with quality checks of submission packages (as applicable)

Qualifications

• Track, scan, code and send documents to the relevant study Work In Progress (WIP) area of PMED or send wet-ink documents to the respective Central Files office location as per the Central File Maintenance Plan (CFMP)
• Photocopy, print distributed and retrieval of documents as needed.
• Maintain basic quality check procedures to ensure accurate maintenance of documents.
• Tracking/ maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only)
• Organization of translations of study documents (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery)
• Support local site management team in the preparation of site-specific documents and cover letters
• Distribute study documents to sites and/or local authorities (e.g. via courier shipments) as required
• Assist with quality checks of submission packages (as applicable)