Job title: Clinical TMF Specialist
Reports to: Director, Clinical Trial Management
The Clinical TMF Specialist is responsible for independently providing support to the clinical study team and managing the Trial Master file life cycle; set up, maintenance, reconciliation and archiving of essential documents in the TMF in accordance with GCP, FDA, MHRA and EMA regulations. TMF specialist may also provide support to the clinical trial manager(s) with all phases of study conduct (feasibility, start-up, maintenance and close out) of clinical trials.
Duties and responsibilities:
- Assist in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents.
- Perform periodic regulatory document QC and reconciliation activities, to ensure inspection readiness and regulatory compliance.
- Assist Clinical Document Management group to set-up and indexing of TMF/eTMF.
- Provide support for:
- Electronic submissions of regulatory registries and institutional review board/ethics committee (IRB/IEC) submissions
- Regulatory or IRB/IEB submissions
- Review and quality check of any regulatory or IRB/IEC submissions
- Clinical operational compliance during audits and/or regulatory inspections
- File study documents onto the TMF in accordance with standard operating and clinical procedures.
- Assist CDML with training and on-boarding study teams (Cara & CRO) on specific TMF or eTMF processes.
- Review TMF documentation prior to filing in the TMF and remediate any issues directly with the functional team.
- Track resolution/closure via tracking mechanisms and uploads to the TMF
- Attend study team meetings and represent clinical operational compliance at team meetings.
- Perform a close out review of study TMF and remediate findings with the study lead and/or external vendors, in preparation for the TMF study closure.
- Ensure the TMF is inspection ready at all times and trial master file documents are filed in a timely manner, in accordance with metrics timelines.
- Assist with internal and external TMF audits.
- Provide support to CTA and CTMs for all phases of the study conduct of clinical trials as needed basis.
Qualifications include but not limited to:
- Minimum 3-5 years of experience in related area.
- Excellent planning, coordination, and time management skills to meet deadlines required.
- Demonstrated organization skills and attention to details.
- Strong computer skills, including proficiency with Word, Excel, Outlook, and PowerPoint, or ability to quickly learn applicable software programs.
- Demonstrated experience working with:
- TMF and eTMF technologies and/or Document Management applications.
- eRegulatory Systems (e.g., Veeva Vault, etc.)
- Knowledge of:
- ALCOA FDA standards, Good Clinical Practice, and Good Documentation Practice, per ICH (E6 (R2), FDA guidelines, European Medicines Agency guidelines, and applicability to all stages of the clinical development process.
- TMF Reference Model, clinical trial activities and related terminology.
- Project and Site level files and corresponding expected documents per level.
Travel: Less than 25%
Candidates must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.