Manager Management
Resume:
MICHAEL L. VENTURA
Stanhope, NJ 07874
*********@*********.***
Cell: 973-***-****
LinkedIn: http://www.linkedin.com/in/mlventura
CLINICAL DATABASE DESIGN PROFESSIONAL
Experience managing an international team responsible for implementation of global and therapeutic area standards, case report form design, clinical database design and maintenance, edit check development and validation. Trained in computer system methodology supporting clinical development projects.
TECHNICAL SKILLS
• Information Systems Management
• 21CFR Part 11/ICH-E6 (GCP)
• Oracle Clinical RDC (eCRF)/Clintrial
• CDISC CDASH/SDTM
PROFESSIONAL EXPERIENCE
SANOFI-AVENTIS PHARMACEUTICALS, Bridgewater, NJ 2002 – 2010
System Quality Expert (July 2008-April 2010)
• Supported Clinical Quality & Compliance (CQ&C) audits of Clinical Data Management (CDM) study, system and processes. Identified and tracked the remediation efforts of system quality issues according to the CDM System Quality Plan, company SOPs and Federal and International Regulatory and GCP requirements.
• Supported CDM quality systems development, implementation and maintenance in accordance with applicable Computer System Methodology (CSM), System Life Cycle Management (SLCM) and regulatory requirements.
• Supported Project Leads with an emphasis on User Acceptance Testing (UAT) script development and dry-run testing.
• Functioned as the primary CDM site representative to other functions in Clinical Development and within the CDM department regarding CDM related system quality initiatives.
Database Site Manager (Oct 2007-Jul 2008)
• Supervised the CRF, Database, and Standards Design (CDSD) group in Bridgewater. Ensured timelines were met and employees were properly trained. Provided assistance to the US CDSD Head in Great Valley, PA..
• Finalized the validation of Global Standard edit checks in Oracle Clinical, maintained the standard Data Validation Plan document, and posted the appropriate information to the company intranet.
World Wide Standards Implementation Manager (Mar 2006-Oct 2007)
• Managed the re-design and maintenance of Global Standard and Therapeutic Area Case Report Forms (CRF), which streamlined collected data, ease of data entry, and data cleaning efforts.
• Managed the re-design and maintenance of Global and Therapeutic Area modules for the legacy Clintrial 4.3 Clinical Database Management Systems (CDMS).
• Managed the development of the Global Library metadata for the new Oracle Clinical installation using the CDISC SDTM model.
• Developed and standardized the Data Validation Plan Template for edit check specifications.
• Authored various internal reference documents for standards and study level database development.
• Managed the International Standards Implementation group and coordinated all activities in the scope of World Wide management according to department processes, budget and established time lines.
Database Designer/Programmer (Data Manager – US Medical Affairs) (Nov 2002-Mar 2006)
• Coordinated Data Management (DM) group redesign of DM Standard Operating Procedures (SOPs).
• Developed new DM SOP training materials.
• Designed new therapeutic specific CRF modules for the Ambien project.
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MICHAEL L. VENTURA
*********@*********.***
Cell: 973-***-****
LinkedIn: http://www.linkedin.com/in/mlventura
Sanofi-Aventis…(Continued)
• Provided validated programs and communicated with the CRF designers to provide the database model and database layout.
• Participated in the CRF standards initiative and identified common edit checks by providing analysis of existing studies.
• Assisted with the study team activities earlier in the process by providing protocol review and CRF design. Presented the advantages of standardized modules and reduced db design timelines by up to 25%.
• Produced study databases according to project specific data models in accordance with global standards, setup of panels, page sections, page templates, and study books.
• Defined and maintained study specific validation and derivation procedures.
• Programmed ad hoc study specific listings and reports.
• Provided technical support to clinical teams and functional groups.
VENTURA SYSTEMS, INC., Advanced Resources Group Sep 2000 – Nov 2002
Clinical Programmer – Assignment: Abbott Laboratories
VENTURA SYSTEMS, INC.,/NRJ Systems Jul 1999 – Sep 2000
Clinical Programmer – Assignment: Hoffmann-La Roche
• Designed and developed Case Report Forms (CRF) using Adobe PageMaker and FrameMaker. Developed a method of pre-annotating CRF modules as per Global Standard Libraries.
• Produced study database structures, data validation checks, and derivation procedures.
• Provided data check definitions, validation and derivation procedures. Communicated with the CRF design group to provide the database model and database layout and the creation of extraction views for reporting and statistical analysis.
• Produced study databases according to project specific data models in accordance with global standards.
• Programmed ad hoc study specific listings and reports.
• Provided technical support to clinical teams and functional groups.
DMR CONSULTING GROUP Sep 1996 – Jul 1999
Customer Support Lead Analyst – Assignment: Merck Clinical Research
• Provided management support of Corporate Policies, Operating Procedures, and Instructions.
• Ensured the continuous flow of clinical trial data collected on laptop computers that was remotely transmitted into an Oracle database and managed the processing within the Oracle core database.
• Coordinated efforts of the clinical team, help desk personnel, standards and quality management groups as well as the application and protocol development teams.
HARDWARE AND SOFTWARE SKILLS
Windows 98/NT/2000/XP Environments: HTML; C/C++; PL/SQL; MS Office (Word, Excel, PowerPoint, Access, VBA); MS Project; MS Publisher; MS FrontPage; Visual Basic; Adobe PageMaker, Adobe FrameMaker, Clintrial; Oracle Clinical RDC
UNIX Environment: Oracle 7/8i; Oracle Clinical; SQLPLUS; Oracle CASE; Asterix packages including Word, Spreadsheet, and Graphics; X-Windows; Motif; IDEF0 Modeling Tool; Arbortext SGML Authoring and Publication System; Workflow Manager
EDUCATION
B.A., Biology, William Paterson College, Wayne, NJ
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