NOTE:
- Pharma Industry experience (couple of years) Clinical Trial Experience (few years) GCP Experience (few years) Not senior level experience (doesn’t need a decade worth of experience) Bachelor’s degree required
- Day to day Mtg of TMF-early planning and setup all the way to study closeout and performing of consolations and archival activities
- Focusing on TMF lifecycle as a whole TMF assigned specific trials to work on Day to day activities include:
- QC of documents (paper and electronic)
- Team meetings (communicating issues to CTA/CRA) Filing
JOB DESCRIPTION:
- 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
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
- Supports Managers in training efforts for new personnel