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Click here or scroll down to respond to this candidateCURRICULUM VITAEName:Candidate's Name
DCRI Position Title:Clinical Data Specialist IIIFG or KRP:Technology & Data SolutionsSummary of ExperienceTwenty years of experience as a data specialist in clinical and scientific research. Managed the data management activities of multiple international trials in several different therapeutic areas. Independent thinker and very good problem-solver.Therapeutic ExperienceOrthopedic Implants (Knee and Hip replacements)Cardiology (Aortic aneurysms, Atrial Fibrillation)Health Dermatology (Submental fullness)Ophthalmology (IOLs)Infectious diseasesEmployment HistoryClinical Data Specialist III, Data Solutions, DCRI (CRO) 11/2022 11/2023Oversees project data management processes and activities as Associate Project Leader; facilitates creation and timely delivery of all data management deliverables within the scope of workOversees design, development and validation of EDC system (as Lead Data Manager) with input and collaboration from project stakeholders; drafts specifications for electronic Case Report Forms (eCRFs), data validation checks, external data integrations, project data status reports and data review listings.Develops and maintains project documentation, including project profile, Data Management Plan (DMP), specifications, testing, project-specific work instructions and training, ensuring audit-readiness and DCRI SOP, ICH and 21CFR compliance at all times.Coordinates with cross-functional team members, sponsor and vendors to reach agreement on project data format, deliverable schedules, disposition, and archival.Reviewed protocols and provided feedback on Data Management sectionsPrepared descriptions of work and budgets for changes to Scope of WorkPrograms Used: Rave, IBM Zelta eClinical OS, RedCAp, Medrio, Confluence, Jira, Microsoft Project/Excel, WordConsultant, Clinical Data Associate/Specialist, Conformis 6/2022 PresentManage, Analyze and generated Reports of EDC data for 8 studies involving the various Conformis personalized Knee and Hip implants.Remote Data management for closing-out studies and working with monitors for minimizing gaps and integrity of data entry.Generation of Regulatory Reports for the 8 studies.Obtained Data-Backup DVDs for the 8 studies for Compliance and Regulatory On-site and Remote storagePrograms Used: eClinicalWorks, Medrio, Microsoft Excel, VB, SASClinical Data Associate, Conformis 10/2018 09/2021Trained people on EDC system (Medrio) and designed database for pilot project using Medrio and eClinical OS.Participated in training for hybrid role including site management responsibilities along with data managementIndependently planned and managed data management activities based on project contracts and sponsor communication for paper and EDC trialsReviewed protocols and provided feedback on Data Management sectionsPrepared descriptions of work and budgets for changes to Scope of WorkOversaw, managed and was accountable to the Project Lead for data managementdeliverables, timeline and budgetOversaw access to data systems on projects, including account managementParticipated in department and organizational initiatives including review and maintenance of SOPsDeveloped SQL ad-hoc reports for internal and external use, including single row functions, multi row functions, nesting and complex joinsWorked with external parties to agree on data transfer format, contents and schedule.NGO(www.maithricharity.org) (Content Developer and Designer) 08/2017 04/2018oDeveloped content and designed web pagesEndologix Inc. (Clinical Data Specialist - Consultant) 11/2015 04/2017oSupported data cleaning activities for 3 studies involving fenestrated stent graft system for the endovascular repair of juxtarenal and pararenal aortic aneurysmsoReconciled data transfer GAPs between OracleClinical RDC, Clindatrix, databases with that in eclinicalOS edcoEnsure data transfer completeness, consistency of data, raised queries, and reviewed responses, and closed queries, SDV'ed data through remote monitoringoTrack progress ensuring projects meet timelines and quality expectationsoHelped in UAT (User Acceptance Testing)oProvided status updates to project team / project manageroHelped study PMs and site monitors in pre-site monitoring visit, close-out site visits preparationsoAcquired specific clinical and therapeutic knowledge related to Endologix studies and productsoReview Adverse Events (AE), and Serious Adverse Events (SAE)oAssured compliance to the study protocol, overall clinical objectives, and FDA regulations, ICH Guidelines, Good Clinical Practice (GCP)oEliminated unnecessary personnel resources by diligent project planning and saved ~ $200K annually.Skills/Programs Used: Merge eclinicalOS, OracleClinical, Clindatrix, Data Management, SASKythera Biopharmaceuticals (Sr. Data Steward - Consultant) 10/2014 11/2015oManaged data using Veeva database and Salesforce Customer Relationship Management (CRM)oPrepared reports and identified data quality issues and discrepanciesoPerformed Data conversion and definition activities and prepared reports on daily basis.oDeveloped clear data sets to enable a standardized collection and integrationoAnalyzed massive amounts of cross-boundary data content with high level of accuracySkills/Programs Used: Data Management, Veeva CRM, Microsoft ExcelTaaratech LLC (Data Manager - Consultant) 10/2013- 08/2014oHands-on experience on data extraction, transformation, loading with various data sources.Virginia Commonwealth Univ.- School of Medicine(Instructor) 06/2009-05/2013oTeaching Instructor of Physiology laboratory course for under-graduate students: pre-med, allied health professionals and nursing.oPerformed software installation, upgrades/patches, troubleshooting, and maintenance of systemsoWritten technical reports and created/maintained in-house chemical databases.Corning Incorporated (Sr. Development Scientist Consultant) 10/2005 12/2008oDeveloped and validated source codes to perform multi-scale modeling and simulationsoModeled and simulated network traffic characteristics for wireless Local Area NetworkoUsed Advance statistical methods to parse and analyze simulated dataoDeveloped Factory Acceptance Tests for Cornings High Throughput Bio-system.oDeveloped Biochemical Assay for protein binding studies using Cornings HTS- Epic system.Weill Cornell Medical College, New York, NY (Instructor) 07/2001 05/2005oAided clinical track professors in early clinical and regulatory affairsoInstructor in Dept. of Physiology using Computational modeling and electrophysiology to study protein folding of small channel protein, GramicidinoInstructor for small group conferences and Bioinformatic to medical studentsoInstructor of Boot-Camp study for Bioinformatics for medical students in the Tri-State area.oPerformed software installation, upgrades, troubleshooting, and maintenance of serversSkills/Programs Used: Fortran, pClamp, Origin, Excel, PowerPoint, Designer, CHARMmAcademic Research 10/1995 06/2001Research Fellow, Dept. of Physiology, Weill Cornell Medical College, New York, NY (10/199506/2001)Research Fellow, Dept. of Physics and Chemistry, Universit de Montreal, Montreal, Canada (07/199509/1995)Research Fellow, Dept. of Physics, Royal Institute of Technology, Stockholm, Sweden (01/ 199506/1995)Educational backgroundoPh.D. in Bio-Physics (Indian Institute of Science, Bangalore, India), 1994oMS in Bio-Physics (University of Madras, Chennai, India), 1987oBS in Physics with Mathematics and Chemistry (University of Madras, Chennai, India), 1985Honors & AwardsoJames R. Houghton Challenger Award for Innovation Teams Optical Picocell (Corning Cable Systems / Science & Technology). Team Member from S&T, Corning Inc., Oct 2006oInvited speaker in CECAM workshop Lyon, France., Jun 2000oWinston Fellow, Norman and Rosita Winston Foundation Fellowship in Biomedical Research, Cornell University Medical College, Jul1995 - Jun1997.Licenses & Certifications & Publications(Recent):oClinical Data Management (CDM) Online CourseUdemyIssued Nov 2022 No Expiration DateIssued Nov 2022 No Expiration DateoCertificate Course in Clinical Research Certificate Course in Clinical ResearchUdemy Issued Oct 2022 No Expiration DateoIntermediate Python for Data Science courseDataCamp Credential ID $6,363,601oIntermediate Python for Data Science courseDataCamp Credential ID $6,363,601oIntermediate R courseDataCamp Credential ID 4311052oIntroduction to SQL for Data Science CourseDataCamp Credential ID #6,314,023oStatistical Thinking in Python ( Part 1)DataCamp Credential ID #6371283oSide-chain interactions in the regulatory domain of human glutamate dehydrogenase determine basal activity and regulationJournal of Neurochemistry Jan 26, 2015Mastorodemos, Konstantinos Kanavouras, Candidate's Name , Maria Providaki, Zoe Petraki, Michael Kokkinidis, Ioannis Zaganas, Diomedes E. Logothetis, Andreas PlaitakisCandidate's Name 10-Jan-2023 |
