Sahithi M

eTMF Specialist with 4 years of experience in clinical trial documentation. Experienced in managing electronic Trial Master Files across multiple studies. Strong knowledge of ICH-GCP and regulatory compliance requirements.

Skilled in document uploading, indexing, and classification. Expertise in performing quality control (QC) reviews of TMF documents. Hands-on experience in site-level TMF review and gap identification. Proficient in QIS (Quality Issue System) management and issue resolution.

Experienced in processing soft and hard deletion requests. Strong understanding of TMF Reference Model and taxonomy. Skilled in metadata management and document version control.

Experience in TMF reconciliation and completeness tracking. Ability to maintain inspection-ready TMFs at all stages.

Experience supporting audits and regulatory inspections. Skilled in generating and analyzing TMF metrics and KPIs.

Experience in coordinating with cross-functional teams to support project deliverables. Ability to manage multiple studies and prioritize tasks to meet project timelines.

Experience in tracking project progress and ensuring timely completion of TMF activities. Strong organizational, communication, and stakeholder management skills.

eTMF Specialist - PPD Clinical - Denton, TX, Remote

(2025-06)

• Perform quality control (QC) review of TMF documents to ensure accuracy, completeness, and compliance with ICH-GCP and TMF Reference Model
• Conduct site-level TMF review to identify missing, misfiled, or non-compliant documents and ensure timely resolution
• Manage QIS (Quality Issue System) by raising, tracking, and closing document-related issues
• Process soft and hard deletion requests for duplicate, incorrect, or obsolete documents
• Ensure metadata accuracy, version control, and proper document classification
• Perform TMF reconciliation and completeness checks to maintain inspection-ready TMFs
• Track and follow up on missing, expected, and overdue documents
• Support audit and inspection readiness activities, including document retrieval and audit support
• Generate and analyze TMF metrics and KPIs (quality, completeness, timeliness)
• Collaborate with cross-functional teams to resolve TMF discrepancies
• Coordinate with the Data Management team to resolve document inconsistencies and ensure data alignment
• Support issue resolution activities by identifying gaps and ensuring timely closure with stakeholders
• Ensure adherence to SOPs, ICH-GCP, and regulatory compliance standards
• Manage multiple studies and prioritize tasks to meet project timelines
• Supporting end-to-end document lifecycle management from upload to archival eTMF Associate / Coordinator - Phathom Pharmaceuticals - Denton, TX, Remote

(2024-03 - 2025-05)

• Perform quality control (QC) review of TMF documents to ensure accuracy, completeness, and compliance with ICH-GCP and TMF Reference Model
• Conduct site-level TMF review to identify missing, misfiled, or non-compliant documents and ensure timely resolution
• Manage QIS (Quality Issue System) by raising, tracking, and closing document-related issues
• Process soft and hard deletion requests for duplicate, incorrect, or obsolete documents
• Ensure metadata accuracy, version control, and proper document classification
• Perform TMF reconciliation and completeness checks to maintain inspection-ready TMFs
• Track and follow up on missing, expected, and overdue documents
• Support audit and inspection readiness activities, including document retrieval and audit support
• Generate and analyze TMF metrics and KPIs (quality, completeness, timeliness)
• Collaborate with cross-functional teams to resolve TMF discrepancies
• Coordinate with the Data Management team to resolve document inconsistencies and ensure data alignment
• Support issue resolution activities by identifying gaps and ensuring timely closure with stakeholders
• Ensure adherence to SOPs, ICH-GCP, and regulatory compliance standards
• Manage multiple studies and prioritize tasks to meet project timelines
• Supporting end-to-end document lifecycle management from upload to archival eTMF Trainee / Clinical Document Specialist - Syneos Health - Hyderabad, India, Remote

(2021-05 - 2023-07)

• Assisted in uploading, indexing, and filing clinical trial documents in eTMF systems
• Supported quality control (QC) checks to ensure document accuracy and completeness
• Maintained basic metadata and document classification under supervision
• Followed TMF Reference Model for proper document filing structure
• Assisted in tracking missing and expected documents
• Supported TMF reconciliation activities and gap identification
• Helped in organizing documents for audit and inspection readiness
• Assisted in document version control and naming conventions
• Coordinated with internal teams to resolve basic document discrepancies
• Supported QIS-related activities by identifying and reporting issues
• Assisted in maintaining document logs and trackers
• Ensured adherence to SOPs and regulatory guidelines
• Supported document lifecycle processes from upload to filing
• Maintained organized and up-to-date TMF documentation
• Learned and applied clinical documentation and compliance standards

Masters - Information Systems & Technologies - University of North Texas (2023-08 - 2025-05)