Joanna Loresto,

Certified GCP Manager, Certified Veeva Vault Clinical Administrator, Certified Clinical Research Auditor, and Data Analyst with expertise in Veeva Vault CRM/Clinical eTMF/CTMS/Quality, Python/Generative AI/Agentic Automation. Twenty (20) years of proficient and broad knowledge of clinical research study processes, study design, and clinical trial monitoring procedures; more than ten (10+) years of consumer goods/manufacturing industry experience. Demonstrated ability to incorporate and strongly adhere to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP)/ICH guidelines/ISO 14155, ALCOA++ of FDA, RUTOLA of CDISC and other regulatory regulations.

Proven project and vendor management skills to work with a variety of different systems, collaborate with cross-functional internal and external partners, and deliver commitments on time, with quality and within budget. In-depth knowledge of the DIA/CDISC Reference Model and regulatory landscape surrounding the clinical trials. Meticulous attention to detail, ability to find potential gaps and implement solutions.

Successfully manage study timelines, CROs, vendors; successfully resolve issues and foster process improvements.

Sr. Manager, TMF and Inspection Readiness (Contract) - JC LORESTO CLINICAL RESEARCH, LLC

(2020-08)

• Establish and maintain TMF governance documentation, including TMF Plans, TMF Specification documents, TMF Migration Plan, TMF Closure Plan, TMF related SOPs and Work Instructions, templates and TMF-related training materials.
• Perform and lead quality reviews of TMFs for completeness, performing record review for accuracy and quality to achieve TMFs that are in an ongoing state of inspection readiness.
• Provide support, training, guidance and oversight to clinical operations, CRO, and other clinical development staff in the management of TMFs, unblinded tasks, and company processes.
• Develop and maintain strong relationships with TMF stakeholders, CROs and vendors, including acting as a subject matter expert for TMF operations, requirements and deliverables.
• Drive internal and external audit/inspection activities and contribute to CAPAs, including resolution and remediation activities.
• Identify critical path of TMF risks and implement proactive mitigation strategies to protect study timelines, regulatory submissions and inspection readiness.
• Creating, managing, and executing/approving validation documentation related to eTMF change and release management including IT change control documentation, user acceptance testing (UAT)/performance qualification (PQ) testing documents such as plans and test scripts.
• Support and lead the migration and archiving of sponsor's TMF.
• Management of the company's eTMF system and support the implementation and integration of any systems or processes that would interface with the eTMF (e.g., Regulatory Information Management (RIM), Quality Management System (QMS), CTMS, etc.), including data mapping between systems, configuring standard processes and workflows across systems, and managing integrations on an ongoing basis as business needs evolve.
• Develop and establish TMF Key Performance Indicators (KPIs), Key Quality Indicators (KQIs) and other metrics for sponsor, CRO and other TMF stakeholders to reflect TMF status and health accurately.
• Establish and monitor TMF performance dashboards and key risk indicators; conduct trend analysis and implement sustainable mitigation strategies to drive operational excellence.
• Collaborates on projects with Information Technology (IT) to ensure effective integration of eTMF systems.
• Partner with Quality Assurance (QA) for the preparation of audits of internal/external partners/vendors. May include: developing training materials and administering training to inspectors, managing inspector access, supporting teams with document retrieval during audit/inspection, providing system-related support, answering questions around eTMF system and procedures, and providing demos or guided-support for the eTMF system.
• Provides strategic leadership and continuous improvement of TMF activities ensuring scalable infrastructure and sustained inspection readiness across clinical programs.

Veeva Vault Clinical Business/System Administrator (Contract) - JC LORESTO CLINICAL RESEARCH, LLC

(2020-08)

• Support TMF system selection.
• Design, configure and implement Veeva Vault systems across multiple modules.
• Collaborate with IT and business stakeholders to support system integration and data migration activities.
• Perform day-to-day administration activities of Veeva Vault system as per approved procedures.
• Oversight of managed services to ensure that system configuration meets business requirements.
• Creating, managing, and executing/approving validation documentation related to eTMF change and release management including IT change control documentation, user acceptance testing (UAT)/performance qualification (PQ) testing documents such as plans and test scripts.
• Management of system operations in Veeva Vault including: Control of system access and permissions, Perform change management activities, Design solutions and manage configuration, Monitor the impact of configuration changes to optimize performance, Liaise with Veeva Vault Users to resolve issues, Create reports and dashboards based on defined requirements.
• Analyze Veeva Vault User enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization.
• Ensure consistent and accurate data flow within and among all Veeva Vault systems.
• Assist in the evaluation of system usage and provide recommendations for operational efficiencies and continuous improvement.

Clinical Documentation Manager - RIGEL - South San Francisco, California

(2018-07 - 2020-08)

Clinical Trial Document Management and eTMF Vendor Management responsibilities including audits/inspections/regulatory submissions, clinical documentation processes and tools, and TMF legacy management.

• Manage the completeness and quality of the eTMF (from start-up to archival), including elements outsourced to CRO.
• Perform the administrative functions for the Veeva Vault and PhlexEview eTMFs.
• Work with study team to ensure that the eTMF is able to fully reconstruct the conduct of a clinical trial and documents are readily available for audits/inspections.
• Lead the development of study-specific TMF Plans to ensure quality standards and specifications are implemented and maintained throughout the course of a trial. Manage procedural document revisions, updating and approving.
• Monitor all document-processing activities to ensure quality and adherence to applicable processes and GCP requirements.
• Report study TMF progress or any issue to responsible study team members.
• Ensure documents which fail TMF quality content and/or TMF inspection readiness review are effectively remediated by internal/external representatives; provide best practice recommendations, as needed.
• Identifies and mitigates risks for new and ongoing projects handling paper and electronic TMF documentation and project specific records.
• Monitor and identify study-specific TMF trends and communicate to the study team.
• Manage eTMF vendor contracts and required access forms; review and approve vendor invoices.
• Evaluate metric reports to ensure progress is current and key deliverables are on track.
• Coordinate with eTMF vendor for the planning and organization of the final and secure archiving of the eTMF.
• Collaborate with vendor to enhance processes and improve system efficiencies as needed.
• Lead or participate in TMF readiness checks, eTMF audits or inspections activities at key study milestones to assess compliance with agreed standards; identify gaps and provide recommendations for process improvements. Complete corrective actions in coordination with the study team.
• Provide support with identifying, retrieving and providing any document requested by the inspector in a timely manner during an inspection.
• Contribute to responses to audit/inspections of TMF findings and facilitate remediation of all TMF CAPA commitments.
• Responsible for the selection and management of appropriate technology support solutions and requirements for the changing landscape of TMF management.
• Facilitate implementation and maintain documentation for system configuration change requests.
• Work with IT and business process owners to ensure optimal use of systems and tools related to eTMF.
• Create, review, update, implement and maintain processes, procedures and training materials to ensure inspection readiness for studies, in compliance with ICH GCP(R2) requirements and ALCOA+ principles.
• Conduct TMF educational workshops/trainings.
• Support off-site storage activities for legacy clinical trial documents in accordance with corporate policy.

Clinical Records Manager (Contract) - PROTHENA BIOSCIENCES - South San Francisco, California

(2017-11 - 2018-12)

• Developed and lead the Clinical Trial Master File (TMF) lifecycle process across functional departments and other stakeholders to drive standardization, harmonization and implementation of TMF/eTMF management and archival.
• Lead the development and implementation of study-specific eTMF procedures and plans to ensure quality standards and specifications are implemented and maintained throughout the course of assigned trials.
• Responsible for ensuring complete and accurate TMFs through consistency and application or adoption of documented TMF procedure(s).
• Worked with study teams to ensure that the eTMF is ready for audits/inspections on a continuous basis.