Senior Site Documentation Specialist

EPM Scientific are currently partnered with a clinical-stage biotech running a global rare disease development programme. They are urgently seeking a Senior Site Documentation Specialist to support a high-priority site documentation remediation project. See a summary of the role below:

Role Overview

• Location:
  
  New York, United States
• Contract Type:
  Freelance / Consultant, 0.2 FTE, 6 Week Contract
• Project:
  Site Documentation Remediation & TMF Oversight for a Pediatric Rare Disease Study

Key Responsibilities

• Review site documentation and essential records at a high-enrolling clinical trial site.
• Identify missing, incomplete, or incorrectly filed documents.
• Partner with the CRO and study team to ensure appropriate filing and inspection readiness.
• Resolve documentation backlogs and reconcile site records.
• Provide expert TMF and clinical documentation guidance.
• Support audit follow-up activities and overall compliance.

Requirements

• Extensive experience in TMF management, document remediation, or clinical trial documentation.
• Strong understanding of GCP, ICH guidelines, and inspection readiness requirements.
• Experience identifying and resolving documentation gaps from audits or quality reviews.
• Ability to work independently and rapidly assess documentation quality.
• Experience collaborating with CROs, sites, and clinical operations teams.
• Excellent communication, organisation, and problem-solving skills.