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Click here or scroll down to respond to this candidateCandidate's Name
Street Address West Lockhaven Dr, Apt FGoldsboro, NC Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLEPROFESSIONAL EXPERIENCEUNC Lineberger Comprehensive Cancer Center Clinical Protocol Office, Chapel Hill, NC (Remote)Contract Clinical Data Management Associate, December 2022 PresentConsult with Principal Investigator, Statistician, and Study Team to determine project requirementsDetermine data to be collected and the appropriate data resources for specific oncology clinical research trialsFormulate data management plansDevelops and implements evaluation methodology to determine completeness and adequacy of the data collection proceduresUnderstand and ensure privacy law and standards, and other applications of GCP to Data ManagementDevelop data collection and evaluation methodologies, including format design, project criteria and requirements, data compilation, relevancy, and usageImplement timely planning, design, and development of study protocol calendars and Case Report FormsManage study setup, testing, and validation for new studiesReview protocols and apply protocol-specified guidelines to the review and cleaning of clinical dataProgram edit checks to query discrepant data, map data points and perform calculationsPerform validation checks to ensure completeness and consistency of dataIssue queries to resolve errors and missing dataReconcile adverse event dataPerform and document procedures for data preparation, including data cleaning, standardization, and analysisDelivering completed datasetsProvide validated and complete data to investigators for abstracts and manuscriptsPrepare monthly, quarterly, and annual data reports for distributionShare data with Federal agencies and other entities, as neededCreate, conduct training on, and implement plans, data entry guidelines, data completion guidelines and other study documentsConsults with staff on data coding problems and assists in developing means to correct the problemsTrain coordinators and CRAs21 CFR Part 11 compliantPharPoint Research, Durham, NC (Remote)Contract Data Manager, May 2022 - August 2022Review study-specific documentation as part of the project team to obtain understanding of study-specific data processing conventions.Prepare data for entry through completion of transmittal verification, data tracking, and completion of manual review processes.Perform data entry in any clinical data management system used by Clinical Data Management. Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes. Investigate and resolve data anomalies.Identify the need for and generate data queries at any point during data processing, based on guidelines set forth in the Data Management Plan (DMP).Issue and review queries for completeness and forward to the project lead or designee.Conduct quality control including case report form to database review processes. Create test data, perform testing procedure of entry screens, and provide test results to the project lead or designee.Work concurrently and accurately on multiple protocols.Execute all coding activities involved with developing and maintaining a clinical trials database for analysis and/or transfer to sponsor.Provide functional oversight of data processing activities including training of staff performing data entry, data cleaning and quality control tasks. Report routine project status and data trends to project lead or departmental management as required.Create case report forms in accordance with the protocol and established standards when necessary.Author portions of or totality of the DMP as required.Serve as resource for project lead and departmental management.Assist in staffing assignments for assigned projects, ensuring that the project is sufficiently staffed with qualified personnel and specific project requirements are met.Provide functional management and supervision of specific projects tasks, as well as conduct timely and through evaluation of work performance of all direct report personnel.Assist in providing in-house instruction and mentorship as part of technical career development for Data Management Interns, including training, progress assessment, and facilitate technical development for direct report employees.Perform all other related duties as assigned.21 CFR Part 11 compliantICON/Docsglobal, Philadelphia, PA (Remote)Team Data Manager, January 2022 April 2022Provided Datam Management on a FSPProvide the team metrics on unanswered queries based on number of days outstanding on a weekly basisManaged 3rd party vendor by overseeing reconciliations and posting monthly transfersProvide the team metrics on outstanding and overdue CRF pages on a weekly basisDevelop both manual and programmed data review checks and lead project team meeting to review those data review checksTest database systems and programmed edit checks against expected outcomesComplete data review activities such as Local Lab reconciliation, SAE reconciliation and Listing reviewCreate and maintain study documentationAssist in providing new study team members access to EDC or changing existing team members role within in EDCStrong knowledge of GMPs, GCPs, USP, EP, Safety regulations, and data integrity.21 CFR Part 11 compliantInternational Drug Development Institute, Inc, Raleigh, NCClinical Data Quality Specialist, January 2020 to December 2021Perform data review activities:Review the answered automatic queries in the EDC system, close them or ask for more clarificationPerform the manual cleaning of clinical data based on SAS edit checks and/or listings and post the relevant queries in the EDC systemPerform reconciliation of SAE and other external data received and follow-up with the external vendors until resolutionPerform quality control activities:Enter dummy data in the test instance of the EDC system for testing purposes of SAS programsTest reports, listings and patient profiles to ensure that they work correctly based on the dummy data enteredReport on findings on these tests and follow-up until resolutionPerform data entry or verification of laboratory normal rangesCreate SAS annotated CRFsProvide the study team reporting which includes reporting trial progress and outstanding issues. Liaise and collaborate with corresponding teams in other IDDI departments working on the same project.Performs reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, and Central Laboratory).21 CFR Part 11 compliantConduent Inc., Cary, NCBenefit Specialist (Contractor), August 2019 to December 2019Completed a 6 week Benefit Specialist trainingAnswer and respond to incoming calls from employees and former employees regarding Annual Enrollment for Lockheed MartinComplete Annual Enrollment for participants in the Health and Welfare databaseProvide guidance to participants on navigating and completing Annual Enrollment elections on the Lockheed Martin Employee Service Center website.Provide information and resolve any issues pertaining to these calls in a timely, courteous and professional mannerPerform, track and log all transactions performed related to Human Resources and/or Benefits processes.Follow up on outstanding issues to ensure resolution, keep the customer informed on the status of research, close out case when complete.Notify Technical Analyst and Team Manager of potential or recurring problems regarding issues.Communicate conceptual elements of Benefits and/or Human Resources rules, regulations.Handle confidential information with sensitivity and discretion in accordance with Data Privacy requirements.Attend all departmental meetings and training classes as required.Utilize written and verbal communication skills which require an emphasis on customer serviceUse computer skills with the ability to navigate multiple software applications at once to provide a positive customer experienceFresenius-Kabi Inc., Wilson, NCQuality Compliance Associate (Contractor), November 2018 to June 2019Conduct and write formal investigations with the assistance of plant personnel and oversight from managerDefining and recommending corrective and/or preventive actions identified through the investigation processConduct and write initial impact assessmentsPerform reviews and evaluate sensitive, confidential informationDevelop recommendations for use by the plant quality assurance departmentPfizer Inc., Rocky Mount, NCQuality Engineer Investigator (Contractor), November 2017 to October 2018Conduct and write formal investigations with the assistance of plant personnel and oversight from managerPerform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative actionPerform reviews and evaluate sensitive, confidential information and develop recommendations for use by the plant quality assurance departmentDefining and recommending corrective and/or preventive actions identified through the investigation processFollowed Change Control process it was relevant for an investigation by reviewing Change Control documentation and ensuring that the proper changes were carried out to completionResearch Triangle Institute International, Raleigh, NCInstitutional Contactor, May 2017 to November 2017Liaison between the U.S. Department of Educations National Center for Educational Statistics Beginning Postsecondary Students Longitudinal Study and High School Longitudinal Study of 2009 and educational institutionsRecruited educational institutions for the Beginning Postsecondary Students Longitudinal Study and High School Longitudinal Study of 2009 by mailings and subsequent telephone or e-mail follow-up to the Institutional Research Director or Chief Administrator who are asked to provide a Primary Coordinator for data collection.Prompted Primary Coordinator to provide data collection which consists of Student Records and Transcripts.Acted as Transcript and Student Records help desk person who responds to educational institution personnel who may have inquiries about data collection and the study web portal.Gave guidance to educational institution personnel in uploading data via Web, Excel and CSV modes to study web portal.Aided educational institution personnel in troubleshooting data upload errors and login issues to study web portal.Developed positive rapport with Primary Coordinators and other educational institutional staff by being sympathetic to their schedules and being ready to answer their questions.Worldwide Clinical Trials, Morrisville, NCAssociate Clinical Data Manager, October 2013 October 2016Assist the Data Manager in each of the data management projects to whichassigned, including reporting trial progress and outstanding issues. Attend or represent the Data Manager at study update meetings or calls with the trial sponsor. Assist in staff training for all projects to which assigned; both direct involvement in training and supervision of staff assigned to training. Liaise and collaborate with corresponding teams in other WCT departments working on the same project. Ensure that all data management operations are conducted to WCT SOPs;contribute to the ongoing revision/improvement of these SOPs.Assist the Data Manager in the creation of project specific documentation for assigned trials, i.e. the Data Management Plan and the Data Management File. Assist the Data Manager to prepare database and edit check specifications. Assist the Data Manager with the creation and validation of SAS checks. Assist the Data Manager with the reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, and Central Laboratory). Perform verification and User Acceptance Testing of configured databases.21 CFR Part 11 compliant Assist the Data Manager in all data cleaning activities. Review SAS listings/SAS tables. Create CRF and eCRF completion guidelines, EDC system manuals and access instructions.Assist the Data Manager in the production of information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor.CDASH standards urtilized during database buildBiormarin Pharmaceutical Inc. at Ockham offices, Cary, NCLead Contract Clinical Data Manager, June 2013 Aug 2013Provide the team metrics on unanswered queries based on number of days outstanding on a weekly basisProvide the team metrics on outstanding and overdue CRF pages on a weekly basisDevelop both manual and programmed data review checks and lead project team meeting to review those data review checksTest database systems and programmed edit checks against expected outcomesComplete data review activities such as Local Lab reconciliation, SAE reconciliation and Listing reviewCreate and maintain study documentationAssist in providing new study team members access to EDC or changing existing team members role within in EDCStrong knowledge of GMPs, GCPs, USP, EP, Safety regulations, and data integrity.21 CFR Part 11 compliantPharm-Olam International, Durham, NCContract Clinical Data Manager, September 2012 May 2013Review data dump listings and generate manual queries as necessaryCreate reports within DataTrak for data review purposesReview query updates for completeness and accuracy in DataTrakPerform project tasks as well as ad-hoc requests from project team membersCelgene Corporation, Durham, NCContract Clinical Data Manager, April 2012 June 2012Performed data review and discrepancy management in Oracle Clinical.Worked with outside vendors when needed for data entryPerformed external data reconciliationPerformed project tasks as well as ad-hoc requests from project team membersPRA International, Raleigh, NCContract Data Manager, November 2011 April 2012Perform data review and discrepancy management in Medidata RaveRun query metric reports and distribute them to appropriate team membersReview Data Listings and generate manual queries as necessaryPerform project tasks as well as ad-hoc requests from project team membersin accordance with project timelinesParexel, Inc. RTP, NCClinical Data Analyst II, October 2009 October 2011Assume the responsibilities of a Clinical Data Manager including utilization of currentstudy documentation.Perform validation review using various validation systems and assign appropriate actionto discrepancies.Generate, track and integrate queries based on validation specifications.Edit database and Case Report Forms in compliance with departmental / projectstandards.Reconcile Labs/Serious Adverse Events.Review Data Listings and address QC findings.Participate and contribute in project team meetings. Perform project tasks in accordance with project timelines.Utilized sequel scripts to isolate data based on certain data parametersQuintiles, Inc. RTP, NCData Team Lead, December 2008 July 2009Provide leadership to the data management team (including programming, clinical coding, data entry and data review) from project start-up through database QC audit and close-outTest database systems and programmed edit checks against expected outcomesLead data review activities and comprehensive QC, including external data reconciliation, Local Lab reconciliation, SAE reconciliation, etc.Coordinate activities with other functional team members (including biostatistics, clinical, project management, etc.), clients, and third party vendors/labsManage data management timelines, plus data management components of project budgetIcon Clinical Research, Durham, NCData Management Project Lead, January 2008 December 2008Coordinate and develop team capabilityAssist with the management of the day-to-day activities of the Data Management study teamDeliver project to quality, timeline, and budget requirementsManage resources and costsMaintain and develop processes and systemsInteract with clients in weekly teleconferences to discuss timelines, project statuses, data issues, etc.INC Research, Raleigh, NCClinical Data Management Associate III, October 2006 January 2008Develops database specifications (e.g., annotates Case Report Forms) and specifications for external data sourceWrites user test plans for data entry screen and electronic edit checks.Write ant test functional specification for electronic edit checks, quality control listings and non-standard clinical study data reports.Perform data review activities such as discrepancy review, query generation, query updates and listing reviewEnsures that all clinical study data captured and maintained by external vendors are incorporated into the study database in collaboration with Clinical Programming. Identifies and corrects discrepancies between the clinical database and data merged into the database from external sources.Runs, reviews and distributes reports to internal study team and sponsors.Tracks data processing progress and communicates problems/backlogs to project team and management.Utilized sequel scripts to isolate data based on certain data parametersMGI Pharma, Inc., Baltimore, MDContract Data Manager, May 2006 September 2006Performed Data Review activities such as query generation both programmed andmanual, review query updates for completeness and accuracy in the EDCenvironmentGenerated and created reports in EDC for manual data review purposesHad Lead Data Manager responsibilities which involved giving weekly progress updates on study issues and study status in Clinical team meetings, maintain study documentationTouchstone Research, Inc., Gaithersburg, MD,Contract Data Manager, January 2006 March 2006Performed Data Review activities such as generation of queries both programmedand manual, query updating, resolving of data entry flagsProduced fail coding reports for coding group and generated coding queries when necessaryMaintained study documentationTracked data trends utilizing sequal scripts in ClinTrial 4.3Nabi Biopharmaceuticals, Inc., Rockville, MDLead Clinical Data Manager, May 2004 January 2006Perform data review activities such as generation of queries both programmed and manual, query updating, resolving of data entry flag reports, run metrics reports, etc.Analyze, review and generate queries based on coding reportsWrite, program and/or revise edit specificationsAttends weekly Clinical meeting representing Data Management to discuss study status and data issuesMaintain study documentation both electronically and in study documentation binderTrain and mentor new data review employeesEnsure that Standing Operating Procedures are being followedUtilized SQL scripts to isolate data based on certain data parametersQuintiles, Inc., RTP, NCLead Data Manager, July 1999 May 2004Interacted with clients in weekly teleconferences to discuss timelines, project statuses, data issues, etc.Interacted directly with Project Managers and CRAsFiled and maintained study documents electronically and in study binderPerformed start-up activities such as screen testing, creating test data, writing and testing of edit specifications, writing data entry guidelinesTrained data review team members as well as the data entry staffOversaw and participate in the generation of queries based on data discrepanciesEnsured that Standard Operating Procedures and work instructions are being followedMonitored study budgetsCoordinated Quality Control proceduresPPD Pharmaco, Inc., Wilmington, NCClinical Data Associate, 1998-1999Assisted in the development and set-up of clinical databaseParticipated in quality control reviews of dataReviewed and wrote queries to clinical sites regarding data inconsistencies; updated CRF and databases from query resolutionsOtsuka America Pharmaceutical, Inc., Rockville, MDData Management Associate, 1997-1998Assisted in the development and review of edit specifications; created test data for edit checks and performed users acceptance testing of the software and clinical databasesReviewed data and CRFs, identified potential data errors, generated Data Clarification Forms (DCFs), obtained DCF resolutions and updated the clinical database as requiredMaintained all required study documentation in the study database binder(s)Coordinated with clinical staff to resolve data issuesClinTrials Research, Inc., Research Triangle Park, NCClinical Data Coordinator, 1995-1997Validated clinical data utilizing computerized reports and other data toolsFollowed data management guidelines and relevant study conventions to make allowable in-house corrections to the study database and CRFsQueried investigator sites regarding missing data and discrepancies; updated case report forms and study databasesResponded to quality assurance audits regarding assigned patientsEDUCATIONCampbell University, Buies Creek, NCBS Biology, 1993James Sprunt Community College, Kenansville, NCAssociate Degree Sciences, 1991DATABASES USEDClintrial 3.3.3, 4.1. 4.2, and 4.4, Oracle Clinical 4.6, DataTrak, Medidata Rave and Inform |
