Project Management
Resume:
Ethan Abbott
Oak Harbor, WA *****
**********@*******.***
Summary of qualifications
Senior Clinical Trials Study Designer/Systems Analyst with Master’s degree in Computer Information Science. Over 12 years experience in Pharmaceutical/Biotech/Medical device industries. Major focus on Clinical EDC systems.
Professional Experience
Theorem Clinical Research (formerly Omnicare) Senior Clinical Study Designer/Database Programmer/ 3/08–6/2012. Performed FSP role for Large Biotech client, specifically:
• Utilizing Medidata Rave, built and maintained 17 complex Clinical trials with multiple cohorts across several therapeutic areas. All completed within budget and timeline.
• Developed/Quality Tested large number (300-500) of Edit Checks per study.
• Maintained active Studies by performing numerous (40+) Change Controls / Migrations.
• Delivered Medidata Rave technical and Client specific process training to over 80 new hires via multiple WebEx training sessions.
• Mentored several new hires through all job functions.
• Chaired bi-weekly Study Design Forum with Client and entire Study Design team
• Developed/maintained Knowledge Management database for Study Designers
• Represented CRO as SME during Client interview/audit process.
• Provided work guidance to Programmers, Data Managers, Quality Testers, User Acceptance Testers.
• Worked closely with project team members, client counterparts and management, to ensure high quality Clinical Trials were delivered within timeline.
• Provided team leadership that positively impacts capabilities that resulted in achievement of business objectives and goals for the company and clients.
• Effectively prioritized and responded to urgent requests within team or from the client.
• Participated in weekly team meetings that included cross functional team members and drove agenda items to ensure the delivery of milestones and timelines for clinical trials.
• Worked closely with Global Librarian to ensure Data Elements and Standards were adhered to during the course of the Study build and maintenance phases.
• Reviewed (draft) protocol from a Study build perspective.
• Attended project kick-off meetings and lead technical database pre-release meetings.
• Maintained 100% training compliance rate with client SOPs.
• Maintained Study Design Knowledge Management database and disseminate knowledge to the study design team members.
• Ensured team members had access to application tools and Electronic Documentation Management systems and documents contained within.
• Coordinated Study Design activities during database build, edit check build and CCF processes.
• Utilized Data Management Plan as a management tool to record and measure progress of Study build and Edit check build.
• During all phases of study build (pre-build kick-off, database, edit check build), recognized areas of potential issues and provided guidance to work around issues.
• Implemented lessons learned and drove process improvements within the project and future projects.
• Prepared for, participated in, and followed up on audits, by addressing client recognized areas of reinforcement, by holding WebEx based instructional meetings with team members.
• Worked with Data Managers and Project Leads to successfully perform Project close-out activities.
• Ensures project deliverables and all documentation were archived within client EDM systems.
• Worked effectively with global virtual teams within different cultural environments.
Medidata Solutions/BioPharm Systems, San Mateo CA Project Analyst 4/2007 – 2/2008
Utilized RAVE EDC system to develop and manage Clinical trials software systems. Specifically:
• Worked directly with clients on 13 Knowledge transfer and ASP projects
• Provided guidance during study build process
• Developed new clinical trials application systems
• Developed specifications for Core configuration and eCRFs
• Developed eCRFs
• Utilized Architect Loader to expedite study development
• Wrote edit checks (simple to complex)
• Wrote derivations
• Performed troubleshooting of production issues
• Provided resolutions for study build issues
• Guided clients through migration procedures
• Managed ongoing clinical trial systems
• Completed 1 month “Medidata University” training course in NYC
• Obtained Medidata Train the Trainer certification
International Programming and Systems, San Mateo, CA Clinical Research Systems Analyst 10/06-3/07 (Contract)
Worked on development, testing, implementation and management of Clinical trials electronic data capturing systems. Specifically:
• Developed and tested validation and edit check procedures
• Wrote test cases for Clinical Electronic Data Capture systems.
• Carried out validation testing of eCRFs.
• Coordinated User Acceptance Testing (UAT).
• Upgraded trials by version and service packs.
• Performed Administrator role for multiple trials.
• Performed system checks by monitoring CIS server and managed server issues.
• Performed trouble shooting of system issues for Users.
• Served as liaison between CRAs/CRCs and Hosting Services Company
• Performed synchronization checks on system data.
• Gathered and analyzed data related to trials performance issues.
• Utilized Phase Forward's InForm Architect tool
• Utilized Oracle backend tool to check and clean data.
Pfizer Global Research & Development, Ann Arbor, MI, Research Informatics Analyst 12/2004 - 12/2005 (contract). Worked with Clinical and pre-clinical data systems in the Informatics division. Specifically:
• Implemented formal SLC methodology to release new in-house software systems and retire legacy systems.
• Utilized Oracle clinical to build clinical trials systems.
• Utilized MS Project and SLC delivery processes to release and support new applications.
• Performed usability testing function of software lifecycle process by testing pre-release software applications in a test environment utilizing actual data and providing feedback to the development team.
• Played integral part within the global matrix by interpreting end-user needs and relating them in technical terms to the global development team.
• Maintained a user issues database and related all issues to development team for implementation in future system releases.
• Developed project level priorities and assisted with strategic planning, by informing senior management of system and software related progress and issues.
• Met deadline for the retirement of legacy systems.
Roche Molecular Systems, Branchburg, NJ Software Developer /Operations Scientist, 1/2002-6/2004.
• Developed an Executive Information System (EIS) that captured all parameters of test and inventory data.
• Performed requirements analysis for system by meeting with clients to determine database objects and all use cases.
• Created database and mapped all database objects.
• Constructed several graphical user interfaces that summarized and held pertinent data that could be readily analyzed by mid and senior level management in order to make business decisions.
• Implemented the project plan and managed the project from conception through entire software life cycle to final delivery.
• Performed usability testing and adhered to software quality methodologies.
• Developed and maintained operational and project related metrics.
• Developed an HTML-based system that enabled scientists to check formulas and conversions from metric to English standard units while in the laboratory.
• The client’s priorities and expectations were established and the scope of the system was determined. The project activities were defined, including a work breakdown structure and a schedule, utilizing MS Project.
• Clearly defined deliverables and dates of delivery were established.
• During each phase of the project, deliverables were submitted to the client who signed off upon receipt. The project was completed two weeks ahead of schedule
Wyeth-Ayerst, Princeton, NJ Research Associate, Molecular Genetics 4/01-12/01.(contract)
Orchid Biosciences, Princeton, NJ Genomic Research Technician 2000-2001. (contract)
Organon Inc., West Orange, NJ Quality Control Microbiologist 1999. (contract)
Merck & Co., Rahway, NJ Chemical Data Registrar/Database Analyst 1999. (contract)
Therapeutic area experience
Pre-clinical and clinical Phases I-IV, and have been responsible for the development and maintenance of EDC based clinical trials systems in the US and International, involving 2-250 sites and 500-1500 patients. Therapeutic area experience includes: Oncology, CNS, Cardiovascular, Neurology, Dermatology, Diabetes, Nephrology, and Psychotherapeutics. Special population groups include Geriatrics and Pediatrics.
Technical/Business Skills
Software Development:
•Database Programming/Web Application Development with VB.NET, ASP.NET, HTML
•Object Oriented Analysis & Design/Iterative software development methodology with Visual Basic, Access, Visio, and UML.
•Unified Process - Business Modeling, Requirements Analysis, Design, Implementation, Project Management, Testing.
•Design of Graphical User Interfaces
•C Programming/Algorithm development.
•InForm Architect
Business:
•Technology Architectures: Methods of optimizing IT for business functions using SIS, Knowledge Management, MIS, DSS, and EIS. Supply chain/Value chain.
•Project Management: Manage Software Development Lifecycle with MS Project, Visio, HTML. Scheduling, Cost factors, Quality, Risks, Customer Satisfaction, Deliverables, Risk Mitigation.
Database:
•Design, Implementation and Administration of Oracle and Access databases.
•Entity-Relationship data modeling.
•Functional Dependencies and Normalization.
•Entity-Relationship to Relational mapping.
•Manipulate data within Access and Oracle databases.
•Created and maintained Oracle server tables and views.
•Access Oracle database with PL/SQL.
EDC:
Inform Architect
Medidata Rave
Web Design:
•Design & Implement Dynamic websites with DreamweaverMX, HTML, DHTML, XML, CGI, and JavaScript. FTP.
Engineering/3DModeling Software:
•AutoCAD
•Solidworks
•Maya
•ISIS
Education
Master of Science, Computer Information Science – Software Engineering/Project Management concentration, LaSalle Univ. Philadelphia PA 12/2003 GPA 3.81
Bachelor of Science, Molecular Biology Eastern University, St. Davids, PA 1998. GPA 3.91
Medidata Certified Study Builder (Accelerate) and Train the Trainer. April 2007
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