Founder of this Southern California based clinical data functional services provider.

*Manage the day-to-day activities of the Clinical Database Management function in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans with an emphasis on effecting resourcing and development of personnel.*Coordinate inter-departmental communication and help resolve administrative and personnel issues.*Manage all aspects of the clinical trial database build process from study start-up to database changes and database archive for Electronic Data Capture (EDC) trials for Agility clients.*Oversee and perform database design, development, validation, implementation, maintenance and support for study-specific and non-study-specific projects.*Monitor, provide input, develop, and assess timelines, ensuring that clinical database development deadlines are met with quality.*Assess resource needs for assigned projects as needed.*Provide input and guidance to the design of clinical databases to the client and internal teams.*Provide system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications.*Oversee and/or develop study-specific or non-study-specific software projects that require specialized programming or scripting.*Troubleshoot and resolve software-related problems.*Develop and maintain study-specific validation documents.*Provide data management support for client-related projects from CRF design to post-database close and archival.*Design and program the Company's internal applications, client-related projects and third-party applications.*Participate in software vendor selection.*Participate in conducting EDC demonstrations and trainings.*Participate in the development and maintenance of SOPs and Work Instructions (WIs) related to data management and database build activities.*Provide leadership for cross-functional and organization-wide initiatives, where applicable.

*Responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications.*Interfaced directly with the internal team, EDC vendors, clients, and third-party vendors to gather requirements and provide status updates.*Provided operational and technical training to end users and junior staff.*Led internal software projects that require specialized programming and/or scripting.*Maintained full scope of responsibility for assigned projects: ensured on-time delivery, communicated the status of projects to internal teams and study teams.*Provided input and guidance to the design of clinical databases to the client and internal teams.*Built and supported clinical databases.*Developed, tested, and validated programs and clinical databases to support client-related projects and third-party applications.*Provided system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications.*Troubleshot and resolved software-related problems.*Developed and maintained study-specific validation documents.*Provided data management support for client-related projects, from CRF design to post-database close and archival.*Designed and programmed Company's internal applications, client-related projects and third-party applications.*Participated in software vendor selection.*Managed user acceptance testing (UAT) for EDC software upgrades.*Participated in conducting EDC demonstrations and trainings.*Participated in development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.*Trained and supervised daily responsibilities of more junior staff as assigned.*Communicated with study sponsors and project teams as needed regarding data, database or relevant project issues.*Presented software demonstrations/training sessions at sponsor meetings or visits.

Agility Clinical is a unique consulting and contract research organization dedicated to working with virtual, small biopharma and device companies with a lean infrastructure. We put our expertise and passion to work helping small companies - particularly those involved with orphan drug development - to move forward and bring important new treatments to patients.•Lead Electronic Data Capture (EDC) developer and manager of EDC development for the organization.•Create and maintain all database-related processes and documentation, ensuring the standardization of each database build.•Mentor/train other data management personnel on the database development process.•Key team member of EDC vendor and safety database selection committee.•Manage user acceptance testing (UAT) for EDC software upgrades.•Serve as integration programmer, utilizing EDC system Application Programming Interfaces (APIs); perform basic SAS programming.•Build special project applications.•Design and develop Case Report Forms (CRFs).•Develop data management plans, data transfer agreements, data management procedures, database user guides, eCRF and EDC design specifications, edit check specifications, user roles and permissions specifications.•Perform medical coding and data review.•Conduct site trainings.•Responsible for database closing activities and attending quality control audits.•Participate in sponsor protocol quality control.•Coordinate and standardize local laboratory formats, units, and reference ranges; ensure all laboratories involved in a study are performing the same tests.•Work closely with Biostatistics team to standardize EDC databases and integration programs in order to best comply with SDTM standards.

•Direct reports: DBAs, Interface Developers, Application Developers, Clinical Programmers, LabWare Administrators, SQA, and Technical Writers.•Provided oversight for all phases of various clinical trials database, application development, and integration projects.•Provided advanced troubleshooting skills to resolve technical problems. Researched, reported, and corrected any quality assurance issues.•Led multiple projects and oversaw team to ensure specifications were met. Ensured all project work was proceeding as scheduled.•Key development projects included: Clinical Trials Data Warehouse, Replacement of Clinical Trials Management System, Laboratory Assay Support Suite, Implementation of Clinical Trials-specific Laboratory Information System, Clinical Trials Web Portal Revamp, Online Local Laboratory Entry System, Centralized Reporting System, and Integration of all Global Clinical Trials Systems.•Core member of Value Stream Mapping Team, a high-profile team tasked with analyzing Clinical Trials Department’s current state and designing future state operational procedures.•In charge of department resourcing and budget.•Interface between BD, Operations, and IT departments.•Researched new technologies and leveraged system development activities to satisfy business objectives and customer requirements.•Recognized and implemented continuous process improvements to prevent/reduce recurrence of quality assurance issues.•Oversaw development and implementation of departmental procedures ensuring compliance with corporate, state, federal, OSHA, and customer specifications.•Interacted with Clinical Trials Data Management and Project Management teams to assess feasibility of automation of manual processes.•Served as Manager, Data Management for six months. Successfully re-organized the Data Management group to maximize productivity and increase data quality.•Certified LabWare Administrator.•Lead Developer - SQL Server 2008/2012, ColdFusion, Flash, Access, VBA.

•Co-developed Clinical Trials Repository (CTR) that unifies global partner laboratory data with US laboratory data.•Wrote CTR use cases by reverse-engineering existing programs.•Developed standard data quality checking programs for CTR extracts.•Architected standard specifications, programs and procedures for extracting data from CTR for lab data transfers to sponsors.•Worked with technical team to develop a database application that would standardize test codes, names, units, reference ranges, and conversion factors, so individual studies can be set up more efficiently.•Reviewed study protocols, global laboratory specification documents, protocol test summaries, and sponsor laboratory data specifications in order to develop study-specific data extraction and quality control programs.•Member of team that is incorporating CDISC SDTM LB domain as company standard, as well as integrating the most up-to-date terminology as ACM’s standard laboratory test coding.•Designed and developed study-specific databases using SQL Server 2005, MS Access, and SAS.•Mentored and advised five data managers on setting up new studies in clinical trials systems.•Developed protocol-specific and cross-protocol ad hoc queries and reports using SSIS and SQL Server Agent.•Reviewed and approved protocol-specific data transfer procedures and validation plans developed by data managers.•Worked with project managers to determine what potential program/procedural adjustments needed to be made when protocol amendments occurred. Worked with data managers to develop new risk-based validation plans.•Assigned as lead data manager to complex protocols. This included working directly with sponsors and CROs to develop custom specifications, developing protocol databases, developing and running data quality checks, managing data queries, and ensuring data was delivered according to the agreed-upon schedule.

GooeyCat provides web and database development, data management and workflow development, data auditing, and graphic design services. Types of companies/organizations include: Academic Institutions, Biodefense Organizations, Architectural Firms, Construction, etc.

-Maintained existing and developed new SQL Server and Microsoft Access databases.-Built ad hoc queries and reports for data analysis.-Analyzed financial and clinical data for Department of Pediatrics.

-Managed DB Developer/Webmaster/DB Analyst/Consultants.-Member of DB Steering Committee: Evaluated new database (db) application and change requests, prioritized projects, and assessed the overall db and data management (dm) needs of the Institute. -Member of Protocol Review Committee: Reviewed all protocols submitted to confirm study populations, dm, data confidentiality, records keeping, and data retention sections.-Modeled/built complex multi-relational study db applications using MS Access and SQL Server. Developed applications using MS VBA, Action Script, Flash Remoting, ColdFusion, Dreamweaver/HTML.-Assessed software/hardware requirements to build customized applications.-Devised strategies for data acquisitions/conversions/archive recovery.-Assisted Clinical Trials Office with CRF design/approval.-Managed db app testing/query/data transfer requests.-Projected staff needs/estimated costs.-Ensured consistent/efficient/accurate data collection across studies/business units.-Led initiative to streamline data processes by centralizing all patient/lab/clinical research/administrative data split amongst 100s of stand-alone dbs. -Authored Vision/Scope, User Reqmts, Functional Specs, Data Flow Diagrams, DB Schemas, Test Scripts, User Manuals, etc. for all new db apps.-Developed SOPs for db listing requests and internal/external data transfers. Produced curriculum for and held training seminars on these procedures.-Wrote data abstraction SOPs for Breast Cancer Dept as well as Specimen Repository Data Entry SOPs.-Ensured data integrity/security by implementing FDA 21 CFR 11 guidelines for db systems, as well as ensuring dbs were modified to comply with HIPAA regulations.-Investigated/resolved data discrepancies from internal/external sources arising from data entry, abstraction, and specimen processing. Discovered reasons for data discrepancies and offered suggestions on how to improve dbs and/or processes to avoid such discrepancies in the future.

-Reported to Director of Biostatistics.-From March 2000 until April 2000 was employed part-time to re-design and re-develop user-interface for breast cancer research database using Access, VBA and SQL Server. In April 2000, was hired full-time to complete the project, as well as to analyze other databases at the Institute.-Successfully re-developed breast cancer database, adding functions to the front-end to automate many of the research staff’s cumbersome tasks. This database was reviewed and given “thumbs up” approval by a well-known Access developer and text-book author.-According to protocol, and using Microsoft Access and VBA, successfully designed and developed a multi-center clinical trial database application that was reviewed and approved by the sponsoring pharmaceutical company.

Provided database programming and data management support for a varied set of companies such as: E-Learning, Data Services Bureaus, Publishing Firms, Executive Search Firms, Specimen Testing Labs, Governmental Financial Departments, Law Firms, Retail Manufacturers, Marketing Firms, and Investment Banking.