Sowjanya Bachina

Lead Trial Master File (TMF) management for 8 active clinical studies, including 1 Phase III oncology study, 6 Phase II studies, and 1 Phase I study. Ensure TMF compliance with ICH E6(R3) Good Clinical Practice (GCP) guidelines, internal SOPs, and work instructions. Serve as a subject matter expert (SME) for TMF processes, providing guidance to internal teams, sponsors, and vendors.

Drive TMF quality, completeness, and timeliness to maintain continuous inspection readiness. Oversee document lifecycle management, including collection, review, filing, and reconciliation of essential trial documents. Collaborate with clinical operations, regulatory teams, and external partners to align on TMF requirements and expectations.

Support audits and inspections by maintaining audit-ready TMFs and addressing findings.

TMF Manager - PREVAIL Infoworks

(2023-11)

• Lead and manage the Trial Master File (TMF) in compliance with ICH-GCP, FDA and EMA regulations, and company SOPs.
• Oversee TMF setup, maintenance, and closeout for clinical studies in eTMF systems.
• Ensure timely filing, completeness, and quality control of TMF documents throughout the study lifecycle.
• Conduct TMF health checks, completeness reviews, and audits.
• Maintain inspection readiness by keeping the TMF accurate, complete, and audit-ready.
• Collaborate with Clinical Operations, CROs, study teams, and vendors to ensure consistent documentation and filing standards.
• Develop TMF plans, filing strategies, and document workflows.
• Track TMF metrics and KPIs, including completeness, timeliness, and quality.
• Manage and support eTMF platforms such as Veeva Vault and Documentum.
• Train study team members on TMF processes, standards, and best practices.
• Support internal and external audits and regulatory inspections.
• Ensure compliance with ALCOA+ principles.
• Conduct TMF-related risk assessments and implement corrective and preventive actions (CAPA).
• Review and approve TMF-related SOPs, work instructions, and process improvements.
• Mentor junior TMF specialists and coordinators.
• Manage vendor oversight for TMF-related services.

TMF Specialist - PREVAIL Infoworks

(2022-10 - 2023-10)

• Performed quality control and remediation for TMF content as needed.
• Created expected document lists (EDLs) at the study, country, and site levels.
• Performed TMF quality control and remediation across functional areas.
• Supported clients during audits and inspections.
• Ensured TMF documents were accurate, complete, and compliant with LMK or client SOPs and regulatory requirements.
• Migrated documents from paper TMF to eTMF and between eTMF systems.
• Promoted strong documentation practices and process improvements in TMF implementation and maintenance.
• Served as the main point of contact for clinical trial sites regarding TMF documents.
• Maintained complete and accurate study records in accordance with SOPs, GCP, and ICH guidelines.
• Maintained continuous regulatory inspection readiness.

TMF Specialist - LMK Clinical Research Consulting

(2020-02 - 2022-09)

• Processed, filed, and tracked Trial Master File (TMF) documents in paper and electronic formats according to study-specific TMF plans.
• Supported project managers during periodic TMF reviews and escalated issues internally and to external vendors as needed.
• Prepared clinical TMF records for consolidation and archiving while coordinating with CRO partners to meet SOP and timeline requirements.
• Supported study managers in tracking milestones and timelines and served as a super user/SME for related systems and processes.
• Organized and maintained project working files and tracked critical documents.
• Performed routine TMF reviews, completed remediation activities, followed up on discrepancies, and documented outcomes as required.
• Provided oversight of TMF quality checks performed by functional teams and CROs.
• Performed periodic eTMF quality control and documented findings in the QC tracker.
• Uploaded documents to the eTMF and maintained paper TMF files as needed.
• Reconciled and transmitted essential documentation and assisted with preparing and distributing meeting agendas and minutes.
• Ensured clinical records were filed on time and monitored TMF completeness and quality, including outsourced components.
• Supported TMF indexing, filing, scanning, reconciliation, closeout, and archiving.
• Processed, filed, and tracked TMF documents in accordance with study-specific TMF plans and the DIA reference model.
• Filed documents at the study, country, and site levels and reviewed site greenlight documents prior to IP release.
• Distributed trial-related documents, study newsletters, and updated manuals to investigator sites throughout the clinical trial lifecycle as needed.
• Performed periodic eTMF quality control, documented findings in the QC tracker, managed EDLs and placeholders, and conducted milestone-based eTMF reviews.

Clinical Trial Assistant - Spark Therapeutics

(2018-02 - 2020-02)

• Reviewed and tracked essential regulatory documents and managed document filing.
• Tracked site activation, patient enrollment, and visit schedules, and updated study management reports as needed. Contributed to the development of clinical trial binders for study sites.
• Supported site identification, CDA coordination, feasibility questionnaires, PSVs, site agreements, regulatory packages, and site initiation visits.
• Supported investigator meeting planning by organizing materials and assisting with logistics.
• Maintained the Trial Master File and filed relevant documents in accordance with ICH-GCP and SOPs, including archiving and electronic filing.
• Coordinated feasibility and study start-up documentation for local, U.S., and global sites, including collection and archiving in the TMF.
• Supported eTMF management and quality control, including site oversight, TMF setup, user training, and resolution of TMF queries.
• Collected, distributed, and tracked receipt of regulatory and trial-related documents throughout the study lifecycle.
• Ensured study start-up and essential documents were complete and filed in the Veeva TMF system.
• Organized and maintained project working files and tracked critical documents.
• Performed routine TMF reviews, completed remediation activities, followed up on discrepancies, and documented outcomes.
• Worked closely with the Site Start-Up team to collect and review essential documents required for site activation.
• Reconciled and transmitted essential documentation and assisted with meeting agendas and minutes.
• Supported TMF indexing, filing, scanning, reconciliation, closeout, and archiving.
• Assisted with audit and inspection readiness activities.
• Coordinated with cross-functional teams to ensure timely TMF filing using transmittal forms and compliance with the TMF plan.
• Supported regulatory and ethics submissions and communication with relevant authorities.

M.Sc. - Clinical Biochemistry - Dr. N.T.R. University of Health Sciences