Hannah Smoot
Rapidan,USA
Summary
Results-driven TMF Specialist with expertise in eTMF systems and regulatory compliance. Proven ability to enhance project efficiency and maintain inspection-ready eTMF standards. Skilled in risk assessment, team training, and fostering collaborative environments that drive project success.
Overview
5
5
years of professional experience
1
1
Certification
Work History
TMF Specialist
Nuvation Bio
12.2025 - Current
- Be the primary contact for internal eTMF, CTMS, and any other clinical systems, including implementation, maintenance, and end user training.
- Support activities to ensure the clinical systems used by Clinical Operations are validated and compliant with regulatory guidelines (e.g., ICH GCP, FDA, EMA)
- Manage the eTMF document lifecycle, including when applicable, uploading, versioning, reviewing, approving, and archiving documents in compliance with applicable regulations and study timelines
- Perform quality control (QC) checks and ensure accuracy, completeness, and compliance of filed documents
- As necessary, assist in the development and maintenance of CTMS, TMF-related standard operating procedures (SOPs), processes, and templates aligned with ICH E6 (R3) and GCP standards
- Conduct routine TMF quality reviews in accordance with the TMF Plan
- Support internal and external inspections and audits related to the eTMF
- Offer technical support and troubleshooting for eTMF and CTMS system users
- Collaborate with cross-functional teams (e.g., Clinical Operations, CROs, Partners etc.) to ensure alignment on eTMF requirements and timelines
- Support Study Operational Leads with the set-up of any TMF with vendors to ensure adequate implementation, including review process, ensuring TMF completeness and managing the transfer of the TMF.
- Performs other related duties and assignments as required
TMF Senior Support Analyst
LMK Clinical Research Consulting a TransPerfect Company
06.2025 - 12.2025
- All duties of a Support Analyst
- Manage project(s) of low to moderate complexity with support from intermediate or senior team members
- Review contractual documentation to understand project scope and expectations
- Provide any required project specific training to team members
- Assign and track project team activities
- Provide support and guidance to assigned project team members
- Ensure adherence to all applicable Regulations, LMK processes, and client requirements
- Monitor project status and progress to ensure adherence to project schedule and budget
- Identify and address issues that jeopardize Project Schedule and Budget
- Function as Trial Master File Subject Matter Expert (SME)
- Maintain any and all documentation to evidence the above
- Host client calls and provide project updates to ensure client satisfaction
- Report on Project Status and progress to LMK leadership
- Escalate issues to LMK leadership, as appropriate
- Collaborate with functional Line Managers to identify performance issues
- Maintain any and all documentation to evidence the above
- Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor
- Perform document Quality Control (QC) remediation (as appropriate) for all TMF content.
TMF Support Analyst
LMK Clinical Research Consulting a TransPerfect Company
10.2023 - 06.2025
- Scan and index documents into the eTMF.
- Perform TMF QC and remediation across functional lines.
- Provide support to clients during inspections and audits.
- Ensure documents maintained in the TMF are appropriate and the content of those documents are accurate, complete and consistent with LMK’s (or clients’) SOPs and regulatory requirements.
- Migrate documents from paper TMF to eTMF (or eTMF to eTMF).
- Ensure strong values and foster innovations in TMF implementation, maintenance and good documentation practices.
- Act as main point of contact for clinical trial sites for TMF documents.
- Maintain complete and accurate study records and proper documentation as per SOPs, GCPs and ICH Guidelines.
- Update and Maintain EDLs as required and directed by Study Manager
- Ensure regulatory inspection readiness at all times.
- Preform GAP Analysis to ensure all proper documentation is filed across all sites, countries, and studies.
Site Management Administrator
ICON, plc.
02.2022 - 09.2023
- Acted as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalated issues and risks as needed.
- Completed essential document collection and review throughout the study lifecycle, organizes and maintained site clinical trial master file (TMF) documents, and maintained site-related data in applicable clinical systems according to procedures and guidelines.
- Ensured timely and complete data entry by site. Performed data review inclusive of site level data review, query resolution, facilitates database closure and freezing procedures as per study plans.
- Performed risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
- Performed all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
Office Manager
Lakeside Real Estate
05.2021 - 02.2022
- Managing daily operation, checking transaction for all needed documentation, communicating with agents during transactions, helping clients who visit the office, scheduling and planning meetings, managing all accounting for business.
- Technology programs used : Microsoft office, google sheets/docs, Bright MLS, Canva, Lone Wolf Backoffice, QuickBooks, Zip forms
Education
Bachelor of Science - Health Science, Psychology
Radford University
Radford, VA12.2021
Skills
- eTMF Systems : Veeva Vault, Phlex, Trial Interactive
- Vendor Systems : Rave EDC, Clario, PPD, Advarra, WIRB, 4G Clinical, PSO, Almac
- Record management
- Quality control
- Client relationship management
- Risk assessment
- Team training
- Attention to detail
- Time management
- Problem resolution
- Client communication
Accomplishments
- Good Clinical Practice (GCP), 10/01/26
- Q-IAOCR: Internationally Qualified TMF Associate, 9826564, 04/01/24
- QM-IAOCR: Internationally Qualified TMF Manager, 9826564, 05/01/24
Certification
- Good Clinical Practice (GCP), 10/01/26
- Q-IAOCR: Internationally Qualified TMF Associate, 9826564, 04/01/24
- QM-IAOCR: Internationally Qualified TMF Manager, 9826564, 05/01/24
Timeline
TMF Specialist
Nuvation Bio
12.2025 - Current
TMF Senior Support Analyst
LMK Clinical Research Consulting a TransPerfect Company
06.2025 - 12.2025
TMF Support Analyst
LMK Clinical Research Consulting a TransPerfect Company
10.2023 - 06.2025
Site Management Administrator
ICON, plc.
02.2022 - 09.2023
Office Manager
Lakeside Real Estate
05.2021 - 02.2022
Bachelor of Science - Health Science, Psychology
Radford University