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Phone: PHONE NUMBER AVAILABLE; E-mail: EMAIL AVAILABLEProfileClinical Data Management/Data Technology professional with experience managing CDM responsibilities within Medidata Rave, developing/maintaining global data standards, Subject Matter Expert in CDISC/CDASH/SDTM mapping and implementation as well as study/library build and best practices, validation/edit check programming, editing/querying clinical data for consistency and accuracy, medical coding, developing/maintaining internal documentation, specifications and processes, departmental training and ongoing mentoring; involved in validation and quality control of new/updated application systems. Expertise Highlights Pharmaceutical/CRO industry Medical Coding Subject Matter Expert Clinical View Design & Management Project Lead in Study Build Development Validation/Edit Check Development Medidata Rave / Oracle Clinical Trainer/Mentor Architect/Database Build/EDC/CTMS Tagging Testing/Scripting/Documentation of software applications Global Data Standardization/Global Librarian Standard Operating Procedure Development CDISC/SDTM Mapping/ImplementationProfessional ExperienceeClinical Solutions, LLC; Mansfield, MAHome-Based in Douglassville, PAProfessional ServicesSenior Clinical Database Programmer September 2019 Present Database design specification in consultation with Data Management, Clinical and Statistical Programming, 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, CTMS Tagging, 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 practice recommendations 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, custom functions 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 Covance (formerly Theorem Clinical Research and Chiltern); King of Prussia, PA Home-Based in Douglassville, PAData Technologies and ProgrammingLead Programming Analyst January 2018 September 2019 Primary responsibility as a DTP Lead who is tasked with study setup tasks and works with the client and Data Management to facilitate the development of the study database and edit check programming as well as acquiring all the signatures for each deliverable and making sure the study development is aligned with CDISC standardization and company policies using Medidata Rave as the database platform. Candidate's Name
202 Mulberry Place; Douglassville, PA 19518Phone: PHONE NUMBER AVAILABLE; E-mail: EMAIL AVAILABLE Standards Specialist and lead member as the Subject Matter Expert in the Global Library Standard development and policies. Work along with study teams to ensure the database setup is built in alignment with CDISC/CDASH. Standards Specialist role consists of building and maintaining global standard database objects and edit checks within Medidata Rave to be used across client study databases. Provide study build/programming support and assist CDM managers in daily technical operations. CTMS Tagging 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. Assist and direct database builders and edit developers India with the development of clinical databases. Perform problem solving and troubleshooting for system procedures and processes that may arise in course of a clinical trial as related to the clinical database. Technical knowledge/support to provide guidance on interfaces or data exchanges between the Clinical database and other database, programming or reporting systems. 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. Chiltern; King of Prussia, PA (formerly Theorem Clinical Research) December 2010- January 2018 Theorem Clinical Research; King of Prussia, PA (formerly Omnicare Clinical Research) Omnicare Clinical Research, King of Prussia, PAHome-Based in Douglassville, PAClinical Data ManagementClinical Programmer IIIPrimary 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 India with the development of clinical databases. SDTM/CDISC Mapping of legacy study data working with Biostatistics Perform problem solving and troubleshooting for system procedures and processes that may arise in course of a clinical trial as related to the clinical database. 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 regarding 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. Octagon Research Solutions, Inc.; Wayne, PAClinical Data OperationsSr. Specialist, Data Integration & Standardization April 2010-December 2010 Function as CDISC/SDTM expert. Perform data conversion from client datasets into SDTM format for submission with the use of Oracle 10g/11g as well as involved in quality control (QC) of study data conversions to make sure data is aligned with mapping specifications and SDTM guidelines. 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. Create and maintain process and project specific documentation. Identify potential process improvements that may increase productivity or quality of the data conversion. Assure project tasks are completed within the identified timeframe. Assure daily tasks are communicated to the resources assigned to the projects. Participate in project / team meetings by presenting on DIS related topics Candidate's Name
202 Mulberry Place; Douglassville, PA 19518Phone: PHONE NUMBER AVAILABLE; E-mail: EMAIL AVAILABLEAccenture; Collegeville, PA (Client Site: Wyeth Pharmaceuticals) Clinical Data ManagementGlobal Librarian, Senior Specialist (Metabolism, Bone & Tissue, Infectious Disease) May 2005-April 2010 CDM Programmer (Neuroscience, Translational Research) April 2003-Nov 2006 Wyeth Pharmaceuticals; Collegeville, PAClinical Data ManagementCDM Programmer (Neuroscience, Translational Research) Dec 2002-April 2003 Technical Advisor (Transplantation) July 2001-Dec 2002 Project Lead/SME on Rave DTE (Dynamic Tabulation Engine) which involving development/maintenance of clinical views per the standard CDISC/SDTM model/internal mapping document. This role involved supervising/training staff members on the functionalities on the application, creating training materials as well as developing/maintaining a project plan to track important peer review assignments and target dates to ensure timelines are met. Maintained the integrity of the Global Library within Oracle Clinical and Medidata Rave ensuring processes as defined in SOPs and Standard Procedural Instructions are strictly followed. Provide expertise on database design/modeling to all operational staff assuring consistency within the establish CDISC/SDTM standards. Participated in global study team meetings ensuring that standard/TA electronic data capture screens are designed in accordance with OC/Rave standard database design. Maintained a comprehensive and detailed understanding of the assigned therapeutic area from an efficacy data collection perspective. Represent CDM on Clinical Project and Study Teams as required to ensure consistency across the various projects and protocols within the therapeutic area. Obtained an ad hoc project lead position at Merck Pharmaceuticals (September to November 2007) to review standard therapeutic area database screens and define mandatory and optional fields for collection within the CDISC/SDTM model. Excellent understanding of the functionality and usability of Oracle Clinical and Medidata Rave system as well as EDC. Designed new and maintain updates to database objects in accordance to standards. Reviewed and promoted objects (DCIs, DCMs, Questions, Validation/Derivation Procedures) to global library. Developed and maintained clinical view definitions through internal view (OC/Rave). Departmental resource responsible for troubleshooting procedural/technical issues. Lead the research and resolution of issues, consulting with colleagues within CDM and IT, to assure dissemination of complete and accurate information. Provide guidance on new/existing applications as well as implement and conduct training in specific areas of expertise such as the validation procedures and project work. Maintained communication of development of internal applications to provide continuous improvement efforts. Created/delivered internal presentations on database or other technological systems. Involved in writing/executing scripts for software validation (OC v4, V4.5, Application Framework (editing tool), GLIMS (CRF imaging tool)). Supervised and trained Off-shore (India) staff on validation/derivation procedure programming and screen/view peer review. Programmed and maintained the validation/derivation procedures. Reviewed and provided input on internal Validation Edit Check Documentation, Design Documents and Change Control Forms. Developed, maintained, and filed appropriate documentation. Reviewed protocols and Case Report Forms/Electronic Data Capture screens to ensure functionality and compliance to standards. Performed final review and testing of the database and validation procedures. Project Leader/Lead Editor within the Transplantation Therapeutic Area: Work closely with the Clinical and Programming teams to assure consistency of validation resolutions according to the editing guidelines. Develop validation specifications as well as participate in the testing process. Effectively organized, prioritized and distributed work in order to produce accurate database transfers in line with project schedules and clinical target dates as well as supervise work of junior project staff by checking the consistency of data editing using study and standard guidelines, creation of queries and updating the database. Candidate's Name
202 Mulberry Place; Douglassville, PA 19518Phone: PHONE NUMBER AVAILABLE; E-mail: EMAIL AVAILABLEOmnicare Clinical Research; King of Prussia, PA June 2000-July 2001 IBAH; Blue Bell, PAClinical Data ManagementDatabase Edit Developer Reviewed Client Study Documents: Protocols, Case Report Forms, Data Management Plans. Developed/managed edit check specifications according to the client study documents. Programmed/QCd Validation Procedures/Edit Checks within the Oracle Clinical. Created test data/documentation to ensure correct edit programming. Rhone-Poulenc Rorer Pharmaceuticals, Inc.; Collegeville, PA Clinical Data ManagementClinical Data Management Associate (CNS) May 1999-June 2000 Clinical Data Management Associate (Anti-Infectives) June 1995-May 1999 Clinical Data Management Associate (Oncology, CNS) Dec 1994-June 1995 Formalized and maintained the organization of the validation process in the U.S. as well as managing/tracking the workload of assigned Data Technician. Worked globally with French colleagues to pursue standardization in U.S. and Europe. Traveled to France annually for team building and departmental meetings. Designed/tested databases, programmed validation tools (edit checks, patient profile, SAS ad hoc listings) and developed data entry conventions. Involved in the overall study validation process, data loading, consolidation, unblinding of data, database freeze/lock process. Provided input in development and design of paper Case Report Forms. Interacted with the CRO/Central Laboratory to meet data/company requirements and timelines. Participated in Working Groups outside project responsibilities: Archiving, ISIS (DE data tracking/transferring tool), Data Processing Team- Trained Study Monitors/CRAs on the functionality of patient profile and the annotated CRF tools, IT/DM team (weekly interaction of problem-solving with IT team); coordinated and implemented the archiving process within the department. Coded Adverse Events (Costart), Prior/Concomitant Medications (Whocode/ATC), Medical History (ICD9). Coordinated/implemented the documentation archiving process within the department. Technical Experience Medidata Rave (since 2007): Architect, Edit Checks, EDC, Global Library, CTMS Tagging, Coder Oracle Clinical: Global Library, Database build, Validations/Derivations, Coding, Discrepancy Database/Query Management Extensive working knowledge of CDISC/SDTM standards/mapping Programming knowledge and familiarity in SQL, PL/SQL, basic C++ (basic Rave edit check development) Proficient in Microsoft OfficeEducationEdinboro University of Pennsylvania; Edinboro, PABachelor of Science in Biology (1994) |
