Remote - U.S. - Document Specialist

Position Summary

The Clinical Trial Document Specialist supports high-quality Trial Master Files (TMFs) across the client's clinical studies, adhering to regulatory requirements, ICH-GCP guidelines, and standard operating procedures (SOPs).

Responsibilities

• Collaborate with the Project Lead, Clinical Study teams, and CRO to ensure a high level of quality and maintain compliance of TMF throughout the study life cycle.
• Support study setup, including contributing to the development of TMF Plan, TMF Oversight Plan, Expected Documents Lists, and archival/transfer as required.
• Monitor operational metrics to support oversight of the TMF.
• Provide Study teams with routine TMF reports and monitor TMFs for completeness and trends, and drive actions with the cross-functional teams as applicable when issues or trends are identified.
• Collaborate with the Project Lead to identify TMF risks and ensure compliance with internal and regulatory requirements.
• Oversee the CRO and internal teams as applicable in preparing, handling, distributing, filing and archiving clinical documentation and reports per standard procedures.
• Maintain and perform oversight reviews (quality checks) of the Trial Master File for all assigned clinical projects.
• Oversee TMF user access management as required.
• Ensure TMF inspection readiness review of TMF is completed and documented.
• Support process improvements as the TMF subject matter expert.
• Attend departmental and trial-specific meetings and discussions, as required.
• Complete other TMF document-related tasks as required.
• Support TMF audits and inspections as required.

Qualifications

• Bachelor’s degree in biological sciences or related field (or equivalent experience)
• Related experience in pharmaceutical / biotechnology industry including records management in a GCP-regulated environment
• Excellent written and verbal communication skills
• Proficiency in MS Word, Excel, and Project, with strong analytical and problem-solving abilities
• Detail-oriented, with strong organizational and time management skills
• Experience with Veeva Vault eTMF

Benefits

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.