Position Summary
We are seeking a TMF Specialist to support the management and maintenance of clinical trial documentation throughout its lifecycle. In this role, you will be responsible for the submission, review, and organization of essential documents within the electronic Trial Master File (eTMF). You will work closely with the TMF lead to provide administrative and quality control support, ensuring documents are audit- and inspection-ready.
This position requires strong attention to detail, the ability to work independently, and a proactive approach to document management. You'll be part of a collaborative and dynamic clinical operations team dedicated to excellence in clinical trial support.
Key Responsibilities
Support clinical trial teams with activities including but not limited to:
Manage the eTMF document lifecycle, including uploading, versioning, reviewing, approving, and archiving documents in compliance with applicable regulations and study timelines.
Perform quality control (QC) checks and ensure accuracy, completeness, and compliance of filed documents.
Assist in the development and maintenance of TMF-related standard operating procedures (SOPs), processes, and templates aligned with ICH E6 (R3) and GCP standards.
Oversee preparation, handling, and archiving of clinical documentation and reports.
Conduct routine TMF quality reviews in accordance with the TMF Plan.
Support inspection and audit readiness activities.
Coordinate the integration and digitization of paper-based or externally held TMFs into centralized systems.
Manage administrative aspects of the eTMF system, including user access and system updates.
Qualifications
Education & Experience:
Bachelor's degree in life sciences, healthcare, or a related field preferred; equivalent work experience will be considered.
Minimum 2 years of relevant experience in TMF management, document coordination, or clinical trial support.
Hands-on experience with eTMF systems is required.
Knowledge, Skills, and Abilities:
Familiarity with clinical trial operations and ICH/GCP guidelines.
Strong attention to detail and organizational skills.
Proficiency with Microsoft Office Suite (Word, Excel, Outlook, etc.).
Excellent written and verbal communication skills.
Ability to manage multiple tasks and work both independently and within a team environment.
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