Senior TMF Specialist - 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, perform completeness checks, and upload documents to the eTMF.
• Act as TMF subject matter expert (SME) and point of contact for study teams and TMF stakeholders.
• Review and classify documents collected from internal and external 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.
• May provide training and mentoring activities for new and current staff.

Requirements

• Bachelors or Associates degree and a minimum of 4 - 6 years of professional clinical trial experience OR a high school diploma and a minimum of 6 years of clinical support experience.
• Demonstrated experience or knowledge with sponsor or CRO clinical research process.
• Understanding of the ICH/GCP guidelines.
• Experience with Veeva Vault electronic trial master file system.
• Strong computer skills (MS Office) including exposure to data/document management systems.
• Good communication and interpersonal skills.
• Ability to build strong relationships with co-workers of various backgrounds.
• Team oriented and flexible; maintaining integrity and high ethical standards.

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.