Highlights:Worked in multiple therapeutic ares and clinical studies from start up to Database lock

Skills:Clinical Data Management, Clinical research, CRF Design, SAE Reconciliation, Vendor reconciliation, Data Base lock

Goal:Seeking Clinical Data Manager post

Membership:Society for Clinical Data Management SCDM

Clinical Data Analyst II 11/Sep/2017 - current
Parexel, Bengaluru, Karnataka India
Industry: Clinical research
My main duties and responsibilities include; Managing delivery of projects through full data management study life-cycle, coordination of daily tasks and delegating to team members, project timeline and risk planning, responsible for several vendors over a number of projects, providing clients with regular updates on data cleaning and timelines, work in concert with worldwide team to ensure all aspects of project running efficiently and according to timelines, responsible for maintaining and reviewing Data Management Study File
Study Build/ set up: Perform below duties during study build process ? Attending kick off meetings for Protocol review ? Reviewing data management plan, DMP documents i.e SAE Recon Guidelines, Vendor guidelines, Data validation Guidelines, data integration plan etc. ? Attending Online screen review meeting with clinical team ? Screen & Edit checks UAT, writing test cases and listings review, SAE and vendor checks, Integration UAT ? Identify potential checks for back end listings on SAS platform ? PD checks identification & development Study conduct: ? Served as Subject matter expert for data validation and SAE reconciliation process ? Weekly communication with Lead data manager for study progress, creating DM Metrics for missing pages, missing visits, pages to SDV, Frozen and lock ? Discrepancy management ? Managing study documentations, approval and version control ? Sharing study related reports and information with study and global clinical team ? Communications with external vendor for Non-eCRF data e.g Lab, ePRO, MRI, Imaging, Biomarkers, PK/PD ? Communication with clinical team for Project management ? Communication with programmers via testing comment logs ? Core to extension study management, cross checks b/w core and LTE study ? eTMF management –Responsible for uploading and tracking all study documents and testing proofs ? PRCF management: Programming request & Change forms are used for initiating new every new or mid study programming activities during set up and conduct on study phases ? Managing post production changes/mid study changes and communication with LDM and Programmers ? Handling data transfer and manual data review for SDTM dataset creation DB lock: ? DB lock and associated documentations ? Responsible for creating clean patient tracker during DB lock ? Attending DB lock meetings with Clinical project managers and LDM ? Identify risks during data cleaning and managing deviations in study ? Working on Data issue log with Bios team ? Review DB lock plan : Interim lock and Final lock ? Subjects transfer from Core to Long term extension studies--

VIT University 08/2007 - 05/2009
Vellore, Tamilnadu, India
Degree: Master's Degree
Major:Pharmaceutical Chemistry
Pharmaceutical Chemistry and Drug design

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