FSP Essential Document Pack (EDP) Reviewer (Open)
Core
Review and approve country and site Essential Document Packs (EDP) for completeness, accuracy, and quality to enable clinical trial site activation.
Role type
Clinical Trial Operations Specialist (Regulatory Documentation)
Builds
Compliant Essential Document Packs for study site activation
Domain
Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory document review, checklist compliance verification, revision tracking, SOP interpretation, clinical trial authorization knowledge, medical terminology understanding, data interpretation, analytical problem-solving
Preferred skills
Local language proficiency, advanced Microsoft Office skills, independent judgment
Technologies
Microsoft Word, Excel, PowerPoint, data tracking systems
Responsibilities
Review country essential documents against compliance checklists, review site essential documents for accuracy, notify submitters of deficiencies and required revisions, review revised packs to confirm resolution, track review details in data systems, maintain knowledge of regulatory guidelines and SOPs