Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management Specialist (CDMS) is responsible for the management and oversight of Trial Master File (TMF) records from set-up through to final archival of the clinical trial, ensuring compliance with company SOPs and processes, and all applicable regulations.
Focusing on inspection readiness, monitors compliance of the TMF and supports preparation of documentation required for regulatory agency inspections and internal audits.
Oversees set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. With support from the management team, performs periodic quality assessments of clinical TMF documents where required.
Contributes to assigned Clinical Document Management (CDM) initiatives.
Responsibilities
% of Time Job Function and Description
70% Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of GCDO ensuring effective lifecycle management of the clinical section of the TMF.
• Key contributor and member of the clinical study team
• Monitors completeness and quality of the Clinical TMF, including elements outsourced to CRO
• Ensures effective communication and issue escalation internally and with external vendors
• Oversees consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process.
• Ensures compilation of CSR appendices in accordance with Shire’s process
20% Supports inspection readiness for GCDO through periodic quality assessment of clinical records.
• Ensures clinical records are filed in a timely manner
• With direction from the CDM Manager, prepares clinical records for agency inspection.
• Supports assigned TMF corrective action plans under direction of Senior CDM/Manager.
10% • Supports CDM initiatives to enhance efficiencies in document management practices
Integrated Resources INC
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