The Documentation Specialist supports the Global Clinical Affairs (GCA) Clinical Operations team by managing the lifecycle of clinical trial and clinical investigation documentation, with a primary focus on the electronic Trial Master File (eTMF). The role ensures that essential documents are complete, accurate, current, and filed in compliance with ISO14155 Good Clinical Practice (GCP) and company Standard Operating Procedures (SOPs). The Documentation Specialist plays a central part in maintaining inspection and audit readiness across the clinical study portfolio.

Responsibilities

• Manage the setup, maintenance, quality control, and archival of the electronic Trial Master File (eTMF) for assigned studies, from study start-up through close-out and final archival.
• Process clinical documents within the eTMF system: indexing, classifying, filing, versioning, and tracking documents against the applicable TMF Reference Model and study-specific TMF plans.
• Perform completeness, quality, and consistency reviews of incoming documents, identifying missing, expired, or non-compliant records and following up with document owners for resolution.
• Collaborate as needed with each assigned study team to determine which study documents need to be collected before, during, and after study conduct, aligned with GCA TMF SOP and established work instructions. Liaise with study team to collect documents at appropriate timepoints.
• Maintain GCA’s TMF tracker to ensure transparency of TMF compliance status and action items. escalate gaps and risks to Clinical Operations leadership.
• Support inspection and audit readiness by ensuring the eTMF is continuously current, and assist in the preparation, retrieval, and review of documents during internal audits and regulatory inspections.
• Serve as a day-to-day point of contact and subject-matter resource for eTMF
• Maintain version control of controlled documents and templates, and support document change control activities in line with SOPs.
• Collaborate with cross-functional stakeholders (Clinical Operations, Regulatory Affairs, Quality, and external CROs/vendors) to ensure consistent and compliant documentation practices.
• Support the development, review, and periodic update of SOPs, work instructions, and TMF-related process documentation.
• Contribute to continuous improvement initiatives for documentation processes and eTMF system enhancements.
• Ensure all activities comply with GCP, applicable regulatory requirements, data integrity (ALCOA+) principles, and company policies.

Skills-

• Solid working knowledge of ISO14155 Good Clinical Practice (GCP), ICH-GCP E6 Trial Master File guidelines, and essential clinical documentation requirements;
• Strong understanding of TMF/eTMF principles, document lifecycle management, and data integrity (ALCOA+).
• High attention to detail and strong organizational skills, with the ability to manage multiple studies and competing priorities.
• Proficiency with electronic document management systems and standard office applications (e.g., Microsoft Office, Smartsheet).
• Strong written and verbal communication skills in English; able to collaborate effectively across global, cross-functional teams.
• Proactive, quality-focused mindset with the ability to identify issues and drive them to resolution.
• Ability to work independently while supporting a collaborative team environment.

Essential Functions of the Role

Education & Work Requirements

Education & Work Preferences

• Bachelor's degree in life sciences, pharmacy, nursing, biomedical sciences, or a related discipline. Equivalent relevant experience may be considered.
• Typically 2-5 years of relevant experience in clinical documentation, TMF/eTMF management, clinical trial administration, or clinical operations within a pharmaceutical, biotechnology, medical device, or CRO environment.
• Hands-on experience with eTMF systems (e.g., Veeva Vault eTMF or comparable)
• Experience supporting audits and regulatory inspections is strongly preferred.

Competencies