Senior TMF Specialist (Contractor) - Remote

Overview

This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard Operating Procedures (SOPs) as appropriate. The Senior Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection ready according to Arcus SOPs and applicable regulations.

In Short

• Work directly with TMF Content Owners to identify issues and perform completeness checks.
• Act as TMF subject matter expert for study teams.
• Review and classify documents from various sources.
• Reconcile essential documents to avoid duplication.
• Support study teams with the TMF quality review process.
• Perform QC and maintenance of eTMF for assigned studies.
• Provide input on revision of TMF related Work Instructions and SOPs.
• Manage paper document filing process for wet-signed documents.
• Participate in audit and inspection readiness preparation.
• Work cross-functionally with internal departments and external resources.

Requirements

• Bachelors or Associates degree and 4+ years of professional clinical trial experience.
• Demonstrated experience with sponsor or CRO clinical research process.
• Knowledge of the Clinical Study Process and ICH/GCP guidelines.
• Familiarity with international clinical trials and document QC process.
• Experience with Veeva Vault electronic trial master file system.
• Strong computer skills including MS Office.
• Good communication and interpersonal skills.
• Ability to work quickly and prioritize effectively.
• Team-oriented and flexible with high ethical standards.
• Ability to build strong relationships with co-workers.

Benefits

• Equal Opportunity Employer.
• Commitment to diversity and inclusion.
• Supportive work environment.
• Opportunities for professional growth.