• Act as TMF SME, including related SOPs and processes, to provide ongoing support to the study team and CRO partners.• Monitor essential document lists, milestones and events to ensure TMF completeness via eTMF functionality.• Support development of the study specific TMF management plan and index in collaboration with study team and CRO partners.• Support study team from study start-up through closeout and archive preparations.• Review metric report outputs with study teams on a recurring basis.• Support holistic quality review and perform spot-checks for quality oversight.• Perform secondary QC on documents to ensure quality and adherence to ALCOA++ principles.

• Served as the primary subject matter expert for all TMF related activities including writing and implementing the TMF plan, filing index and essential documents list and coordinating user access and training for sponsor and CRO users.• Updated SOPs and training to reflect the current status of the trial and the TMF. • Tracked and reported on progress of study site activation, patient enrollment, and monitoring visit activities by working with in-house departments and third-party vendors. Worked with CRO partners on best practices for study enrollment. Reviewed monitoring visit reports for completeness and consistency.• Reviewed study plans including monitoring, communication and data management plans.• Worked on the migration of the CRO-held TMF (Veeva) to an in-house TMF (Veeva) including ensuring documents migrated properly and the system was configured properly.

• Functioned as main sponsor subject matter expert for trial master file activity for multiple oncology studies by providing metrics, guidance and training to sponsor and CRO teams. Updated TMF plans, filing indexes and essential documents lists and coordinated user access for sponsor and CRO users.• Utilized reports and dashboards within Veeva Vault eTMF to keep TMFs audit ready by monitoring completeness, quality and timeliness.• Managed quarterly QC reviews by offering leadership and support on which documents needed review and which issues needed attention. Tracked reviews through to completion.• Updated SOPs and other process guidance to reflect the current status of the trial and the TMF.

• Functioned as main sponsor subject matter expert for TMF-related activities including the migration of the eTMF from a CRO system (Veeva) to an in-house eTMF (Veeva).• Created and provided metrics on completeness, quality and timeliness of the eTMF, uploaded and approved documents, updated plans, indexes and essential document lists and provided training to internal and external team members. • Created and implemented processes to create consistency and quality across company’s studies with relation to TMF management.• Performed quality reviews of the TMFs for three phase I/III gene therapy trials and followed through on the remediation of all identified action items including working with CRO partners.

• Promoted from TMF Support Analyst to manage eight TMF quality control, migration and document management projects ensuring that the quality, timeliness and completeness of each TMF was always inspection ready. • Served as a liaison between the internal team and clients to find and remediate potential audit concerns offering leadership and support on best operational processes.• Improved and implemented standard operating procedures and other training documents while serving as a leader to more junior colleagues.• Worked in systems including Veeva, Wingspan and Trial Interactive with companies ranging from small biotech firms to global pharmaceutical companies.

• Coordinated the daily activities of four oncology studies to ensure that each study ran efficiently. • Ensured that each TMF (Wingspan) was always inspection ready. • Kept information in the clinical trial management system (CTMS) up to date and accurate.• Supported project managers with overall project management including meeting management, study supply tracking, and ensuring adherence to protocol, ICH and GCP requirements. • Mentored other team members on project and company-specific goals.

• Promoted from Clinical Study Associate to manage a paper based TMF project for a dermatology product preparing for submission to the FDA. • Served as a liaison between the internal team and clients to find gaps in the TMF and created a plan to address them. • Contacted sites to ensure that their files were available for potential inspection. • Participated in a mock-FDA audit to prepare for the submission and address any potential inspector’s questions.

• Coordinated the daily activities of two oncology studies to ensure that each study ran efficiently. • Sent site feasibility questionnaires and collected essential documents for site start-up. • Ensured that each TMF was always inspection ready.

• Coordinated the daily activities of six oncology, CNS and vaccine studies to ensure that each study ran efficiently. • Supported project managers with overall project management including meeting management, study supply tracking, and ensuring adherence to protocol, ICH and GCP requirements. • Ensured that each TMF (ELARA) was always inspection ready. • Kept information in the clinical trial management system (CTMS) up to date and accurate.• Coordinated with third-party vendors for CTMS and interactive voice response system (IVRS) accounts.