The role involves aiding and providing assistance to all members of the Inspection Readiness Project Team (including NDA and Inspection Readiness Lead, GCP documentation specialist, Clinical Project/Trial Managers, Regulatory, etc.) in overseeing TMF-related tasks, encompassing both in-house and outsourced TMF activities. The TMF Specialist will ensure continuous TMF review for inspection readiness, operating within established study protocols under the supervision of the Inspection Readiness lead or designated personnel.
- Execute quality control and/or completeness checks in line with the company's SOPs and operational best practices pertaining to document management, ensuring the precision of files within TMFs; Assist in reviewing document quality data and audit outputs.
- Aid in the establishment, maintenance, and archiving of Trial Master Files/ eTrial Master Files, aligning with the company's Standard Operating Procedure (SOP), GCP, EMA, and FDA regulations.
- Collaborate with the Inspection Readiness Team and Clinical Project/Trial Manager to monitor eTMF activities, milestones, and metrics.
- Generate eTMF metrics for project teams and follow up with vendors/project teams if necessary.
- Assist/support project teams in preparing for both internal and external audits/inspections.
- Progress towards becoming an eTMF systems subject matter expert while developing TMF expertise.
- Under the guidance of Inspection Readiness project team members, aid in tasks typically associated with GCP Documentation Specialist studies, such as site visits, CRA management, reviewing clinical documents/reports, generating and reviewing ICF templates, reviewing IMP release packets prior to initiation, etc.
- Act as a primary contact point alongside SME for internal and external teams concerning TMF-related processes and activities.
- Collaborate with the internal cross-functional project team and vendors to address discrepancies and ensure timely completion of internal tasks related to TMF deliverables.
- Compile and organize documents required for eTMF submissions; track, name, scan/upload, code, file, and retrieve documents upon request from project team members.
- Uphold a working understanding of and adherence to relevant ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures.
- Complete routine administrative tasks punctually (e.g., timesheets, metrics).
- Keep training records up to date per the company's SOPs, processes, and procedures.
- Undertake career developmental activities/tasks as needed.