• Database design specification in consultation with Data Management, Clinical and StatisticalProgramming, Clinical Coding, and Safety• Collaborate on/update global library as appropriate per best practices and new standards• Design/develop and test clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports• Perform User and Site Administration to include site set up and assignment of roles, permissions and eLearning requirements• Verifies completeness of study deliverables prior to release• Performs peer review for the studies built by other EDC Developers• Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules and Standard/Custom Reports• Manages timely-quality deliverables for the study teams for assigned protocol/study(s)• Conduct training on EDC database use to support internal users• Functions as an EDC Subject Matter Expert (SME) providing guidance and best practicerecommendations to Data Management, operations teams and other stakeholders• As SME is responsible to provide escalation of study specific functional issues,application/vendor issues, testing and validation needs, enhancement requirements, customfunctions and/or custom reporting• Support development and review of SOPs, and Work Guidelines to promote consistency• Identify additional opportunities for standardization and departmental efficiency• Ensure compliance with eClinical and industry quality standards, guidelines and procedures

Formerly ChilternPrimary function is a Lead Programmer/Study Build Project Leader who manages all aspects of study start-up from final protocol to database release into production; works one on one with the client and internal colleagues to ensure all work is being completed as expected per the approved timelines.In addition, my role consists of being a Study Builder and Edit Check Programmer for assigned client studies including the following responsibilities within Medidata Rave:- Involved in multiple working groups consisting of client and internal staff to work towards goals of new processes and development.- Mentor database builders and edit developers in the development of clinical databases.- Perform problem solving and troubleshooting for system procedures and processes. Technical knowledge/support to provide guidance on interfaces or data exchanges between the Clinical database and other database, programming or reporting systems. - Provide CDM system(s) technical support to users including liaison and support to Global IT/Help Desk with regard to CDM system(s) issues and problems. Ensure efficient communication of problems and resolution; provide ongoing support, detection and resolution of errors. - Interact with Biometrics and other departments concerning database contents and structure. If necessary, assist with statistical reporting procedures following the Biometrics departments SOPs and guidelines.- Global Librarian role which consists of building and maintaining global standard database objects and edit checks within Medidata Rave to be used across client study databases.

Formerly Theorem Clinical ResearchPrimary function is a Lead Programmer/Study Build Project Leader who manages all aspects of study start-up from final protocol to database release into production; works one on one with the client and internal colleagues to ensure all work is being completed as expected per the approved timelines.In addition, my role consists of being a Study Builder and Edit Check Programmer for assigned client studies including the following responsibilities within Medidata Rave:- Involved in multiple working groups consisting of client and internal staff to work towards goals of new processes and development.- Mentor database builders and edit developers in the development of clinical databases.- Perform problem solving and troubleshooting for system procedures and processes. Technical knowledge/support to provide guidance on interfaces or data exchanges between the Clinical database and other database, programming or reporting systems. - Provide CDM system(s) technical support to users including liaison and support to Global IT/Help Desk with regard to CDM system(s) issues and problems. Ensure efficient communication of problems and resolution; provide ongoing support, detection and resolution of errors. - Interact with Biometrics and other departments concerning database contents and structure. If necessary, assist with statistical reporting procedures following the Biometrics departments SOPs and guidelines.- Global Librarian role which consists of building and maintaining global standard database objects and edit checks within Medidata Rave to be used across client study databases.

Primary function is a KickStarter Leader who manages all aspects of study start-up from final protocol to database release into production; works one on one with the client and internal colleagues to ensure all work is being completed as expected per the approved timelines.In addition, my role consists of being a Study Builder and Edit Check Programmer for assigned client studies including the following responsibilities within Medidata Rave and Oracle Clinical:- Involved in multiple working groups consisting of client and Theorem staff to work towards goals of new processes and development.- Mentor database builders and edit developers in the development of clinical databases.- Perform problem solving and troubleshooting for system procedures and processes. Technical knowledge/support to provide guidance on interfaces or data exchanges between the Clinical database and other database, programming or reporting systems. - Provide CDM system(s) technical support to users including liaison and support to Global IT/Help Desk with regard to CDM system(s) issues and problems. Ensure efficient communication of problems and resolution; provide ongoing support, detection and resolution of errors. - Interact with Biometrics and other departments concerning database contents and structure. If necessary, assist with statistical reporting procedures following the Biometrics departments SOPs and guidelines.- Global Librarian role which consists of building and maintaining global standard database objects and edit checks within Medidata Rave to be used across client study databases.- CDISC/SDTM data integration mapping specification which involves reviewing study datasets, analyzing the data collected per SDTM domain as well as specifying the programming rules to fit the data into the CDISC model for FDA reporting and submission.

Primary function as a Study Builder and Edit Check Programmer for assigned client studies including the following responsibilities within Medidata Rave and Oracle Clinical:- Provide study build/programming support and assist CDM managers in daily technical operations. - Interact with client regarding CDM tasks as well as be an active participant in regularly scheduled meetings about process and database features/bugs within the EDC system. Involved in multiple working groups consisting of client and Omnicare staff to work towards goals of new processes and development.- Assist and direct database builders and edit developers in the development of clinical databases.- Perform problem solving and troubleshooting for system procedures and processes. Technical knowledge/support to provide guidance on interfaces or data exchanges between the Clinical database and other database, programming or reporting systems. - Provide CDM system(s) technical support to users including liaison and support to Global IT/Help Desk with regard to CDM system(s) issues and problems. Ensure efficient communication of problems and resolution; provide ongoing support, detection and resolution of errors. - Interact with Biometrics and other departments concerning database contents and structure. If necessary, assist with statistical reporting procedures following the Biometrics departments SOPs and guidelines.- US Oversight Lead working with India colleagues to ensure study management of the ‘push to production’ processes to meet client timelines.- Global Librarian role which consists of building and maintaining global standard database objects and edit checks within Medidata Rave to be used across client study databases.- CDISC/SDTM data integration mapping specification which involves reviewing study datasets, analyzing the data collected per SDTM domain as well as specifying the programming rules to fit the data into the CDISC model for FDA reporting and submission.

·Propose project strategies based on outcome of source data review, contract specifications and project timelines. ·Create data conversion plan and maintain project binders. ·Function as SDTM expert. ·Mentor and train employees. ·Interact with CDS and represent Octagon at meetings or CDISC working groups. ·Function as data conversion expert: Train and mentor employees in the use of the ETL tool, troubleshoot the ETL tool, and identify strategy for data conversion for a given project. ·In depth knowledge of SAS programming or programming concepts. ·Provide post ETL and pooling strategies for a given project. ·Create and maintain process and project specific documentation. ·Assist in the organization and presentations at client meetings or internal meetings. ·Identify potential process improvements that may increase productivity or quality of the data conversion. ·Complete project status reports. ·Function as Octagon’s DIS representative to the client e.g. participate in client meetings, assure issues are communicated to client and resolutions are obtained in a timely manner. Team responsibilities: ·Assure project tasks are completed within the identified timeframe. ·Assure daily tasks are communicated to the resources assigned to the projects. ·Create and maintain staffing plans; complete and maintain project plans and status reports. ·Participate in project / team meetings by presenting on DIS related topics; create meeting agendas/minutes.

Project Lead on Rave DTE (Dynamic Tabulation Engine) which involves creating and maintaining clinical views per the standard/study CDISC mapping document. This role involved supervising/training other staff on the functionalities on the application and creating tip sheets on better working practices when creating views. Maintain the integrity of the Global Library within Rave and Oracle Clinical ensuring processes as defined in SOPs and SPIs, are strictly followed. Provide expertise on database design and data modeling to all operations staff and assuring consistency with established OC standards in accordance with SDTM/CDISC mapping.Create new view definitions and modify existing view definitions. Maintain a comprehensive and detailed understanding of the assigned therapeutic area from an efficacy data collection perspective. Represent ACE on Clinical Project and Study Teams as required in order to ensure consistency across the various projects and protocols within the therapeutic area.Ensure consistency in database and CRF design within a therapeutic area. Provide technical support and expertise in all aspects Rave, Oracle Clinical and RDC. Lead the research and resolution of issues, consulting with others within or outside the department, to assure dissemination of complete and accurate information. Maintain awareness of developments in technology internally & externally with regards to CDM in order to provide input to continuous improvement efforts. Provide presentations on database/other technological systems.Train and supervise Off-shore (India) staff with standard data packages and screen/view peer review as well as Global Library validation promotion. Obtained a short contract project lead position at Merck Pharmaceuticals (Sept- Nov 2007) to review standard therapeutic area database screens and define mandatory/optional fields for collection.

Responsibilities same as below (Wyeth Pharmaceuticals, CDM Programmer)Additional responsibilities:~ Manage the transition of programming work to Bangalore, India as well as train the programmers in the day-to-day CDM process and facilitate interaction between the programmers and Data Management Liaisons.~ Excellent understanding of the functionality and usability of the Wyeth RDC system.~ Involved in the re-engineering process of the Data Management department and provide input in the development of flow chart processes and detailed job responsibilities as well as overseeing the CDM Programming deliverables to ensure timely finalization of documents.~ Facilitate training to CDM colleagues in a formal environment in regards to the new re-engineering process and what is required in form of documentation and deliverables for Validation/Derivation Procedures.~ Participate in Analysis and Database Design (ADD) Meeting ensuring that standard/TA validation procedures are standardized and designed in accordance with OC database design standards.~ Involved in the validation process of the OC 4.5 upgrade with regards to the validations/derivations.

Reviews Case Report Forms and Protocols for assigned studies.Review, provide input and execute Validation Check Documents, Design Documents and Change Control Forms with regards to Validation Procedure programming as well as providing input towards improvements with day-to-day work.Responsible for programming and maintaining the validations for the Neuroscience and Experimental Medicine therapeutic areas within Oracle Clinical v4 using PL/SQL.Peer review documents/validations which ensures completeness of standard and project specific validations.Representative of GDVT (Global Data Validation Team).Provide global technical support and expertise in all aspects of GCD. Lead the research and resolution of issues, consulting with others within or outside the department, to assure dissemination of complete and accurate information.Act as departmental resource for resolution of procedural and technical issues.Maintain awareness of developments in technology external to ACE in order to provide input to continuous improvement efforts.Involved in the validation process of upgraded systems such as OC, Application Framework (editing tool), GLIMS (CRF imaging tool

Review protocols and Case Report Forms on assigned studies to assure functionality and compliance to standards; perform final review and testing of the database and validation procedures.Function as the departmental technical resource and assist in development of new technical processes; disseminate pertinent information and provide guidance on new and existing applications to global project team; implement and conduct training in specific areas of expertise such as the validation procedures and project work; work with interdisciplinary groups to evaluate new software and procedures, for example, Oracle Clinical V4.0 and Application Framework editing tool. In addition, perform execution and resolution validation on in-house applications.Represent Clinical Data Management in multidisciplinary settings through participation, presentation and interaction within the corporation and throughout the industry, for example, participating in the OCUG meetings (Oracle Clinical User Group involves multiple representatives from pharmaceutical companies and CRO's).Project Leader/Lead Editor of the new Renal Transplantation Study: Work closely with the Clinical and Programming teams to assure consistency of validation resolutions according to the editing guidelines; develop validation specifications and overlook as well as participate in the testing process; effectively organize, prioritize and distribute work in order to produce accurate database transfers in line with project schedules and clinical target dates; overlook work of junior project staff and new team members by checking the consistency of editing using study and standard guidelines, creation of DCF's and updating the database.Mentoring: Responsible for ongoing training of assigned new hires

Database Edit Developer Review Study Documents: Protocols, Case Report Forms, Data Management PlansCreate edit check specifications according to the study documents Convert English edit check specifications from the Data Managers to Omnicare CR Standard/Additional Edit Check documents (Excel)Create test data/documentation to ensure correct edit programmingProgram Validation Procedures/edit checks within the Oracle Clinical Database System (Version 3.1.1) using PL/SQL Knowledge in the Oracle Clinical database structureKnowledge in creating data listings in Oracle Discoverer (Version 3.1)Composed the Additional Edit Check document - to be used in conjunction with the Standard Edit Check documentComposed the Univariate/Multivariate Edit Numbering System

Formalized and maintained the organization of the validation process in the U.S. as well as coordinating the workload with the Data Technician; worked globally with French colleagues to pursue standardization in U.S. and Europe.Designed/tested databases, programmed validation tools (edit checks, patient profile, ad hoc listings), Data Entry Conventions; heavily involved in the validation process, consolidation.Participated in development of Case Report Forms, protocols, timelineInteracted with the CRO to meet data/company requirements.In addition, participated in Working Groups outside project responsibilities: Archiving, ISIS (DE data tracking/transferring tool), Data Processing Team- Trained Study Monitors/CRA's on the functionality of patient profile and the annotated CRF tools, IS/DM team (weekly interaction of problem-solving with IS team); coordinated and implemented the archiving process within the department.

Clinical Data Management Associate, Anti-Infectives Therapeutic AreaWorked globally with French colleagues to pursue standardization in U.S. and Europe.Designed/tested databases, programmed validation tools (edit checks, patient profile, ad hoc listings), Data Entry Conventions; heavily involved in the validation process, data loading, consolidation, unblinding, database freeze/lock process.Coded Adverse Events (Costart), Prior/Concomitant Medications (Whocode), Medical History (ICD9).Participated in development of Case Report Forms, protocols and timelinesInteracted with CRO/Central Labs to meet data/company requirements.In addition, participated in Working Groups outside project responsibilities: ~ Database Set-up, Edit Check and Patient Profile teams,testing of validation tools and coordinated and implemented the archiving process within the department.

Reviewed validation tool reports (edit checks, patient profile, ad hoc listings) as well as performed Costart, Whodrug and ICD-9 coding.