Clinical Documentation Specialist

Support Trial Master File (TMF) set-up, maintenance, update, archival and closeout (if applicable) in accordance with company SOPs, sponsor requirements, and applicable regulations. Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions, and archiving. Conduct detailed and appropriate quality checks (QC) on TMF documents at defined time points, including any paper originals required. Ensure that privacy and security standards are met and adhered to. Ensure that documents are maintained in accordance with retention practices. Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines. Other duties as assigned. Necessary Skills and Abilities: Effective communication, and interpersonal skills with ability to partner with cross functional internal and external stakeholders. Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures. Exhibits a good understanding of general quality assurance concepts and practices. Highly organized with a strong attention to detail. Proficiency in web-based systems and project management applications (e.g., Microsoft Office, SharePoint, etc.). #J-18808-Ljbffr