Senior Site Documentation Specialist (Contract)
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
- Start date: ASAP
- Location: New York, United States
- Contract Type: Freelance / Consultant, 0.2 FTE, 6 Week Contract
- Language: English
- 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.
If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.
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