QC Specialist ETMF

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

Overview

Trial Master File (TMF) Quality Control (QC) Specialist plays a critical role in ensuring the accuracy, completeness, and compliance of the TMF, which is the central repository of essential documents for a clinical trial. TMF Quality Control Specialists will maintain project level perspective, focus, and communicate effectively as the quality control subject matter expert.

Key Tasks & Responsibilities

• Perform meticulous QC review involving a thorough check of TMF documents to ensure they meet quality criteria, are complete, accurate, and align with the TMF plan, applicable regulations (e.g., ICH-GCP, FDA, EMA), and internal Standard Operating Procedures (SOPs).
• Verify completeness of all required documents, as defined by the TMF Index and TMF Plan, are present. This includes checking all pages of multi-page documents
• Check for accuracy of the information within documents is correct and consistent
• Ensure proper filing and indexing by verifying that documents are filed in the correct locations within the TMF (especially in eTMF systems) and that metadata (e.g., document type, date) is accurate. A misfiled document is considered a missing document
• Identify discrepancies and gaps by proactively finding any missing documentation, inconsistencies, or deviations from established standards
• Communicate findings and discrepancies to relevant parties and liaise with stakeholders including study teams, clinical operations, data management, regulatory affairs, and Contract Research Organizations (CROs), to facilitate resolution
• Maintain detailed records of QC findings and monitor the progress of corrective actions until issues are resolved and Track remediation status
• Provide input for TMF health reports, including key performance indicators (KPIs) related to timeliness, completeness, and quality
• Support audit and inspection readiness by actively participating in preparing the TMF for regulatory inspections and internal/external audits, addressing any findings or issues identified.
• Collaborate in the development, maintenance, and update of study-specific TMF Plans and TMF Indexes
• Provide feedback for the continuous improvement of TMF processes, tools, and systems
• Liaise with study teams and other staff to fulfil job responsibilities and activities
• Complete departmental projects as assigned in accordance with specified timelines, eCS SOPs/WIs and regulations
• Train, mentor and monitor other quality control specialists to ensure delivery of quality projects
• Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures
• Other duties as assigned
  
  

• Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field)
• Excellent knowledge of English
  
  

• Minimum 2-3 years in Pharmaceutical/Biotechnology industry or equivalent
• Strong knowledge of ICH-GCP guidelines, DIA TMF Reference Model, and other relevant regulatory requirements (e.g., FDA, EMA)
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards preferred
• Experience with electronic Trial Master File (eTMF) systems (e.g., Veeva, Trial Interactive)
• Experience performing quality control activities of clinical trial deliverables preferred
• Ability to manage multiple priorities and work independently or as part of a team
• Excellent verbal and written communication skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent team player
  
  

• Proficiency in Microsoft Office Applications, specifically MS Word, MS Excel and PowerPoint