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, perform completeness checks, and upload documents to the eTMF
• Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs
• 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
• Perform data entry and reconciliation in various clinical systems and tracking tools
• Provide input on revision of TMF related Work Instructions and SOPs
• Support the management and oversight of the CRO study-specific trial master files
• 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 with essential regulatory documents
• Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-out
• Demonstrated knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
• Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
• Experience with Veeva Vault electronic trial master file system(s) including uploading, reviewing, quality checks (QC), approval of study required documents.
• Strong computer skills (MS Office) including exposure to data/document management systems
• Good communication and interpersonal skills
• Good time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment

Benefits

• Remote work flexibility
• Opportunity to work on impactful clinical programs
• Collaborative team environment
• Professional development opportunities
• Supportive management