Gina Budman

About Gina Budman

At LeCDMS we: Consult small companies with limited resources and structure. Build DM teams and processes that ensure regulatory compliance. Become our clients\' extended DM team. Perform EDC builds and ongoing administration. Ensure your study is properly analyzed by our Biostatisticians and SAS Programmers. Our Clinical IT Masters (CTIMx) will inter-connect our clients\' systems and/or design Clinical Apps to ensure patient data in your databases is reliabe and of the highest quality.Gina:• Senior professional. Led DM groups through successful FDA and internal audits and submissions. • Able to build positive relationship with clients, co-workers, vendors, CROs, researchers, various internal/external supporting organizations and management. Created and managed budgets, schedules and staff. • Have thorough understanding of device and drug research processes, as well as current industry successes and challenges. Have managed CROs and various vendors from the sponsor’s side, and worked for a CRO. • Have in-depth understanding of current regulations - including CDISC standards, GxP, CFR 21 Part 11, Stats Programming, Systems and Validation. • Have advanced knowledge of current technology. Led selection, design, UAT, installation, training and validation of multiple clinical systems and electronic tools. • Have excellent problem solving, decision-making skills. • Possess thorough understanding and have current hands-on experience performing all tasks related to clinical DM, such as vendor selections, study start-up through closure processes, DMPs and SOPs creation, database builds, data entry management, data extracts, reporting and reviews, CRFs design. • Former lecturer at UCSC and San Jose state: intense and extensive “Electronic Data Capture”, which included strategies for the development of standards, validation and installation processes and SOPs, and “Clinical Data Management” course.

Experience

1. CEO and Founder

   Leading Edge Cdm Solutions, Inc

   Jul 2014 — Present

   Effectively and efficiently guided all data management activities for clients’ companies.Performed all CDM tasks: EDC selections, EDC builds (various systems), selection of ePRO vendors, CRF/eCRF design and review, creation of DMPs, DEGs, UAT planning and conduct, ongoing data review, SAE review, MedDRA and WHO DD coding, preparing databases for the analysis – i.e. locking and all pre-locking activities, managed CROs. Hands-on leader and professional:Supported, trained and influenced clinical teams to effectively set up the studies and manage information flow in EDC environment according to sponsor protocol requirements, and appropriate regulatory, company(-ies), and departmental guidelines. Provided full user training and support. Created processes and SOPs for the Clinical DM/Biostats Programming teams. Managed contracts and budgets of clients and vendors. Serious about timelines, identified contingencies and risk planning to meet overall timeline goals.

Skills

• Quality Assurance
• Clinical Data Management
• Oracle Clinical
• Biotechnology
• Sas
• Clinical Trials
• Regulatory Affairs
• Lifesciences
• Iso 13485
• Immunology
• Clinical Development
• Cdisc
• Regulatory Submissions
• V&V
• Gxp
• Software Documentation
• Edc
• Therapeutic Areas
• Ctms
• Clinical Operations
• 21 Cfr Part 11
• Validation
• Medical Writing
• Biostatistics
• Change Control
• Medical Devices
• Clinical Research
• Capa
• Pharmaceutical Industry
• Sop
• Computer System Validation
• Fda
• Pharmaceutics
• Technology Transfer
• Regulatory Requirements
• Pharmacovigilance
• Oncology
• Protocol
• Gmp
• Infectious Diseases