Leader in the collection, organization, format and storage of clinical trial data using the latest CDISC (CDASH and SDTM) guidance's for (e)CRF, database, and analysis dataset designCore team member on NDA taskforce coordinating activities for data integration supporting the Cardiokine ISS and ISEIdentify, monitor and resolve activities associated with the scope of services associated with outsourced Data Management ServicesReview and approve Data Management Plans containing data management systems, case report forms, specifications, database structures, edit check specifications, query resolution procedures, discrepant data procedures, dictionaries, dictionary coding, data QC and QA procedures, and other data management activities performed by CROs (See Summary above for current trial activitiesCore team member for data harmonization with the SDTM for 19 legacy and 18 Phase II/III studies in preparation for NDA submission

Direct Data Management activities between US and European offices, approximately 13 DM staff Manage Global Phase III registration protocols, and CROs, for two NDAs Oversee the development, execution, and maintenance of Data Cleaning Plans. Including legacy data integration plans, data validation manuals, annotated CRFs, dataset definitions, pre-entry review guidelines, project timelines and numerous other quality control documents and toolsManaged data repository for all clinical data which include all legacy data from internal study databases and those transferred from CROs, Central Lab's, Pharmacokinetic Analytical data, and managed un-blinded data to provide blinded datasets to Biostatistics and other blinded data reviewersDirect validation, testing, and implementation of Data Management programs and software Evaluate electronic data capture and electronic workflow productsWrite and implement Data Management SOP's and Working Practice'sAssure adherence to 21 CFR Part 11, GCP/ICH, and Good Clinical Data Management Practices

Managed staff of 25, including 5 Clinical Data Project Managers Directed the validation, testing, and implementation of in-house Data Management software Write and implement Data Management SOP's and Working Practice'sManaged pivotal Phase III trials for two "top-10" Pharma companies

Manage 23 employees in the Data Management Department. Direct reports include: Project Leaders, Clinical Data Monitors, Clinical Data Specialist, Data Auditors, Data Entry, and Administrative StaffDirected and managed CTMS' first Phase III global registration protocol leading to NDA approval for one of our "top 10" Pharma clientsDirected the development, maintenance, and proper usage of Data Cleaning PlansWrote and implemented Data Management SOP's and Working Practice'sCreated documentation and training for compliance with FDA's 21CFR Part 11 as well as with CBER's guidance for industry, "Computerized Systems Used In Clinical Trials" Evaluated and maintained CTMS project/staffing ratio with approximately 5 clients concurrentlyReviewed and evaluated all client "Request for Proposal" documents, evaluated staffing requirements and appropriate qualifications, and logistics of timelinesPrepared bids for full service Data Management projectsRe-engineered the Clinical Data Management processes to decrease time to clean database and increase efficiency Spearheaded the development and implementation initiative for a QA/Compliance department within CTMS

Core team member for the Electronic Data Capture initiative, a US/UK team formed to evaluate, test, and implement new data collection technologies. These technologies included items ranging from electronic diaries to remote data capture of clinical dataDesigned clinical trial case report forms, CRFs, from protocols. Exercised excellent data collection methodologies to ensure quality and usability of clinical trial data collected for statistical analysis as well as pharmaceutical publicationsResearched and designed standard international CRF modules. These modules were key in standardization of US and UK clinical trial dataInteracted with international staff and Medical Data Sciences Department personnel to determine types of data to be collectedAssured international standardization of CRFs and all related database attributesMaintained and promoted standardization of the GlaxoSmithKline Data Dictionary, a module within the in-house Oracle database management system

Programmed data entry screens using EntryPoint 90Created and maintained clinical trial databases using SAS® and an in house propitiatory database management systemPerformed data transfer for special projects from EntryPoint 90 files into SAS® datasets and generated SAS® listings to evaluate data integrityCreated and maintained necessary database validation documentationProject team member for pivotal Phase III trials used in NDA submissions

Created and maintained clinical trial databases using SAS® Wrote and executed computer programs to validate clinical trial data, reviewed and analyzed output from these programs to identify data anomalies and potential errorsReviewed and proofread data entry output; resolved data errors and made corrections to the databaseConducted meetings with Clinical Research Scientists to oversee the resolution of pre and post entry discrepancies in investigational drug study case report formsReviewed CRFs prior to data entry in search of problematic data as well as visually searched for data discrepancies that were undetectable by computer validation checksProject team member for pivotal Phase III trials used in NDA submissions