Data Management
Resume:
RUDRANI N
********@*****.***
SUMMARY
Over 7 years of extensive experience which include 5+ years of Clinical Data Management and Healthcare research. Experience using major database management tools and process, in various therapeutic areas
SKILLS
●Proficient in managing studies from study start up, conduct to database lock (eCRF design, data validation specifications, UAT testing, discrepancy management, data cleaning activities, SAE reconciliation and external vendor data reconciliation)
●Hands on experience in creating Data Management Plans, CDR Checklists, Edit Checks, Issues and Decisions Logs, SOPs
●Hands on experience in Data validation and verification, CDM protocol reviewing, CRF Review and Tracking
●Knowledge in using medical coding dictionaries like MedDRA and WHOdrug dictionary
●Proficient in performing User acceptance testing (UAT) including validating data entry screens, writing the test scripts and validating the edit check specifications
●Proficient in EDC systems, such as ClinTrial, Medidata Rave, OC-RDC Inform
●Dexterous in phases I, II, III clinical trial database screen testing, database cleaning and discrepancy management.
●Expert in therapeutic areas of Diabetes, Cardiovascular, Opioid and Alcohol dependence disorders.
●Extensive experience in Data reporting tools, such as SAS, jReview, Inform reports and Elluminate.
●Performing quality review for work done by other data managers and coordinating with other team members.
●Hands on experience in SAS programming - Working knowledge in SAS reporting procedures to generate tables and listings.
●Good knowledge in FDA, Drug Discovery Process, ICH and GCP guidelines
●Possess strong ability to quickly adapt to new applications and platforms
●Excellent in multitasking, interpersonal / organizational skills and leadership quality
●Strong interpersonal communication, presentation, verbal and written articulation skills
PROFESSIONAL EXPERIENCE
INDIVIOR INC. MAY 16 – PRESENT
CLINICAL DATA MANAGER
●Worked on Phase I trials - From study start up to Database lock.
●Conducted and involved in the study Kick-off meetings; Involved in Study protocol and CRF review.
●UAT- Lead and involved in the Phase I and II study database testing: Creating and distributing the test scripts and leading and communicating the UAT plan between the internal and external teams.
●Participated in Monthly data review, which involved creating data listings and distributing to the team and see to the query resolution with the CRO.
●Involved in SAE and External data and lab reconciliation
●Reviewing and updating the Data Validation Procedures (DVP), Data Management Plan (DMP) to ensure data consistency.
●Develop and maintain general data management Standard Operating Procedures (SOP's) as well as study specific Work Instructions (WI's) related to the data management needs of specific projects
●Prepare and manage the Data transfer specifications (DTS) for external vendors and leading the test and all data transfers throughout the study.
●Involved in creating and maintaining the database checklist,
●Responsible for Maintenance of Clinical Study Documents and archiving as appropriate in TMF.
●Works with and manage the cross-functional team meetings the other functional groups (Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities
●Hands on experience in maintaining Data Management timelines and metrics
●Supervised and trained project personnel
●Generate and review ad hoc listings, reports and quality control documentation to facilitate validation of the clinical database.
●Interact with CROs when CDM services are outsourced: reviewing approving data management documents and deliverables, monitoring CRO performance.
●Responsible in creating presentations to facilitate understanding of the Data management processes for other departments, clinical sites, and seminars.
DAIICHI SANKYO PHARMACEUTICALS MAY 12 – APR 16
CLINICAL DATA MANAGER
●Hands on experience in all data management activities from CRF design to Database Lock according to all appropriate regulations and Good Clinical Practice (GCP) guidelines
●Contribute to the preparation of protocols, CRFs and prepare or review Manual Review Guidelines and study specific Data Entry Guidelines
●Assisted the Database Administrator with the design of the clinical study database in accordance with relevant procedures Create dummy data for testing data entry screens and edit checks
●Hands on experience on CRF annotation with CDISC standards
●Worked in development of trial validation plan related documents and reviewed final CRF design, validation checks and reports necessary to assure high quality and consistent data Review.
●Develop edit checks specifications; review CRF for completeness and discrepancies; enter/resolve data clarifications.
●Generates clinical data listings by using Ad-hoc reporting tools in EDC; identify issues with validation procedures during study conduct and communicates findings, address database questions and resolve database queries.
●Review Clinical Trial data in accordance with data review conventions to identify erroneous, missing, incomplete or implausible data
●Coordinated with coding group to ensure coding of medical history terms, adverse events and concomitant medications are done on a timely basis
●Performed SAE reconciliation and external data reconciliation in accordance with all applicable procedures.
●Review discrepancies generated in Clintrial and Review Data Clarification Forms with Clinical-Operations staff; process clinical data collection forms; implement change control for clinical databases
●Lead the database lock activities along with the CDL :Cleaned the data for freezing and database lock Interface with Clinical Research Organization to review problematic queries and resolve outstanding queries
●Review Vendor – CRA, Data Management, Safety, Clinical and Medical queries for resolution per sponsor guidelines
●Handled the tasks of maintaining data management project file documentation, finding and reporting the status of data management activities.
NOVARTIS., INDIA OCT 11 – APR 12
ASSOCIATE CLINICAL DATA MANAGER
●Worked in therapeutic areas of Oncology and Diabetes clinical trials of phases II and III.
●Assisted the CDL in all Data Management processes involved from study start up to database lock.
●Reviewed protocol, supported study team for start-up activities prior go-live in accordance with the guidelines of protocol.
●Developed Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
●Performed QC for the Discrepancies and maintaining the defect trackers.
●Involved along with DM team in performing data review, SAE reconciliation and external data reconciliation according to all applicable procedures and guidelines.
●Reviewed and reconciled to reflect the vendor tasks
●Assisted in developing edit / data validation checks used as tools for the data review and discrepancy management activities.
●Coordinated with other team members for data review and maintain data issue logs and follow up on query resolution for the clean data.
●Performed database quality control audit prior to database lock.
●Involved in the UAT testing and preparing the External data transfer specifications.
●Assisted the team in Database lock and Data retrieval activities along with other team members.
NOVARTIS., INDIA AUG 09 – SEP 11
CLINICAL SAS ANALYST
●Excellent experience in SAS programming using BASE SAS, SAS/ACCESS, SAS/PH, SAS/GRAPH, SAS/MACRO, SAS/SQL, SAS/ STAT
●Created SDTM Data sets for Lab, AE, DM, EX and from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation
●Developing SAS programs for data cleaning, analysis, and reporting of clinical data, including sophisticated data manipulation and creating customized listings/reports of clinical data
●Modified existing SAS programs and created new programs using SAS MACROS to improve ease and speed of modifications as well as consistency of results
●Responsible for providing proper validation, including testing and documentation in accordance with GCP and company standards
●Good knowledge of various databases and SDTM datasets.
●Experience in Creating SAS Datasets, Data manipulation, Reports, Tables, Listings and Graphs (TLG)
●Involved in doing Edit checks, Validation of Analysis datasets, Tables & Listings
EDUCATION:
Bachelor’s of Computer Science & Engineering
Jawaharlal Nehru Technological University
INDIA
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