Tech Stack

Description

You will collect, review, maintain, and archive essential documents for the Trial Master File (TMF) in compliance with GCP, ICH, and regulatory guidelines. You'll manage TMF oversight, support study teams, and collaborate cross-functionally to ensure document quality and completeness throughout the trial lifecycle.

Requirements

• A.A./B.S. degree (preferably in a scientific or healthcare-related field) preferred; High school diploma required.
• B.S. with 2+ years relevant experience including extensive experience with Veeva Vault TMF; or H.S. diploma with 6+ years relevant experience.
• 2+ years of TMF QC Review and knowledge of clinical documentation content required.
• Knowledge of and ability to apply applicable regulations and guidelines (e.g., ICH/GCP/Good Documentation Practice).
• Expert knowledge of cross-functional TMF content requirements throughout the trial.
• Proficiency in Microsoft Office Suite, especially Excel for tracking, sorting, filtering, and managing large sets of metadata.
• Excellent communication skills (written and verbal).
• Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment.
• Strong attention to detail and organizational skills.
• Ability and drive to follow through on detailed tasks to closure.
• Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Development and maintenance of TMF Plans.
• Demonstrated understanding of the DIA Reference Model filing structure and contents.

Responsibilities

• Responsible for TMF Oversight development and execution, ensuring all clinical documentation is collected, handled, transferred, and stored via secured and authorized methods, ensuring compliance with global and local standards, requirements, and guidelines.
• Manage TMF performance objectives for end-to-end processes ensuring quality, timeliness, and completeness throughout the lifecycle of the study by overseeing and/or ensuring ongoing reviews to confirm documents are collected and maintained per ICH guidelines and global regulatory requirements.
• Perform the role of the Clinical Records Associate for all Clinical Trials at 4DMT throughout the TMF lifecycle, from study start-up and document collection to oversight and archiving.
• Participate in Quality Assurance audits and/or regulatory authority inspections.
• Support Study Teams to proactively maintain current Expected Documents List (EDL) counts and to file essential documents promptly according to TMF Plans and Indexes, including adjustments due to unanticipated events during trial conduct.
• Identify study-specific TMF compliance gaps (missing or low-quality documents) and track resolutions to closure quickly.
• Manage the performance of external vendors responsible for TMF-related deliverables.
• Escalate issues and/or process improvement suggestions and collaborate cross-functionally to define and implement solutions, Veeva Vault system changes, or corrective and preventative actions.
• Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools.