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Clinical Data Manager resume example with 8+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Professional Summary

Respected professional with experience in coding, maintaining medical charts and improving patient documentation. Smart Health Information Management Director driven to resolve issues and conflicts effectively while remaining calm in all types of situations. Offering decision- making, leadership and communication talents.

Skills
  • Computer Skills:
  • Windows 2000, XP, Mac OS X Applications: Word, Excel, Access, Power Point, Outlook,
  • Oracle Clinical, J Review, ClinTrial 4.5, Oracle Clinical 4.05, Inform, Electronic Trial
  • Master File (eTMF), EDC, Lotus Notes, Data Management 8.2, SQL Navigator 4.3,
  • Integrated Review (IR), Crystal Reports, DataFax, MedDRA, WHODRUG Windows NT
  • 4.0/2000, XP Adobe Writer (Forms Plug-ins)
  • Team Building
  • Effective communication
  • Accurate documentation
  • Health records review
  • Database finalization
  • Discrepancy management
  • Data oversight
  • Good Telephone Etiquette
  • Attention to Detail
  • Analytical and Critical Thinking
Education
, Expected in Certificate in Pharmacy Tech : - GPA :
Lagos State University Lagos Nigeria , Expected in 08/2011 Bachelor of Science : Business Administration - GPA :
Work History
Partners Healthcare System - Clinical Data Manager
Boston, MA, 03/2017 - Current
  • Oncology, Cardiovascular, Respiratory, immunology, Endocrine/Metabolism, Infectious
  • Disease
  • Medical Device, CNS
  • Relevant Skills and Experience
  • Guidelines for Good Clinical Practices and the Code of Federal Regulations/ICH
  • Guidelines
  • Database cleaning and discrepancy management
  • Generated and designed DCF for data clarification
  • Data validation and verification
  • CRF review and tracking
  • Dictionary coding MEDRA, WHOdrug, Working on phases I, II and III clinical trial
  • Database testing
  • Working knowledge of Medical Terminology, Anatomy and
  • Physiology, Pharmacology, Pathophysiology
  • Quality Control (Q
  • C)
  • Coding Procedures
  • Laboratory data review and maintenance
  • Query Generation/Discrepancy Resolution
  • Data retrieval/Data Listings, SAE Reconciliation
  • Utilized Oracle Clinical, OCRDC, Medidata Rave, Inform, JReview, Microsoft
  • Office (Word, Excel, Access, PowerPoint) and in-house query and tracking systems
  • Ensured communication, coordination and collaboration among Data
  • Management staff, with other groups in the department and other departments in a global environment
  • Designed, implemented data validation to ensure data quality
  • Provided timely reporting of outstanding queries, Case Report Form flow
  • Review of patient profiles, data listings, and study summary tables
  • Elevated standards of quality through establishment of effective plans
  • Ensures User Acceptance Testing (UAT) is carried out and documented
  • Highlight issue(s) and work with programmers to ensure resolution
  • Monitor discrepancy management to ensure appropriate quality of data by regular checks during study conduct versus the Data Quality Plan
  • Reviews data to gain understanding and knowledge of the study to accurately assess study status and data quality
  • Organize, coordinate, monitor surgery, chemotherapy, pathology, radiology, and radiation therapy reviews, and accumulate the data from these reviews as determined by the protocol
  • Assist 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
  • Validate data entry screens and edit check programs
  • Organize electronic data loading
  • Run batch validations
  • Work with IT staff to address technical problems or system enhancements affecting data systems
  • Actively participate in study debrief meetings, implements data management learning and Contributed to activities to improve and maintain the quality and effectiveness of data management processes within the function
  • Review and process clinical trial data to ensure the accuracy and consistency of clinical trial database
  • Perform data tracking and reviewing for in-house review through use or creation of CRF tracking sheets
  • Perform in-house review of CRF for adherence to protocol requirements and project specific requirements
  • Document and address any errors, omissions, or inconsistencies found during data review and work with both internal and external project teams to resolve issues as needed
  • Maintain all necessary documentation to support the accuracy of the clinical trial database
  • Maintain necessary records documenting all updates to the clinical trial database
  • Perform the validation of data fields captured in the database against the CRF when appropriate
  • Validate the completeness, accuracy and consistency of the clinical trial database on an ongoing basis using ad hoc queries.
  • Collaborated closely with physicians and nursing staff to improve quality of patient records documentation.
  • Implemented new coding and billing procedures that helped alleviate number of denied claims from insurance carriers.
  • Participated in committees to discuss electronic health records and methods to improve overall workflows.
  • Upheld critical security standards when managing user access actions such as setting up and removing accounts.
  • Built and deployed plans, reports, validation procedures and entry processes for data management needs.
  • Received and processed stock into inventory management system.
  • Assisted with database upgrades and migrations by performing user acceptance testing.
  • Utilized data regarding industry trends to shape solutions and approaches.
Partners Healthcare System - Clinical Data Manager
Somerville, MA, 01/2015 - 02/2017
  • Documented and addressed any errors, omissions, or inconsistencies found during data review and worked with project team both internal and external to resolved issues as needed
  • Managed and resolved discrepancies and DCF integration and resolving/ working with listings
  • Assisted in managing the conduct of studies; monitored patient enrollments and randomizations, and designed Study Chair to ensure patient safety
  • Maintained all necessary documentation to support the accuracy of the clinical trial database, maintained necessary records documenting all updates to the clinical trial database
  • Reviewed data to gain understanding and knowledge of the study to accurately assess study status and data quality
  • Performed QC audits of the clinical trial database against the CRF and resolved queries to establish an accuracy rate
  • Set up and monitor systems for rapid tracking and reporting of dose-limiting toxicities, toxic deaths, severe adverse events (SAE), treatment failures, and other critical study end points as appropriate
  • Ensured CRF data resolutions were managed consistently, efficiently and timely in order that databases could be declared clean and locked according to strict performance standards
  • Provided timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data
  • Actively participated in study debrief meetings, implements data management learning and Contributed to activities to improve and maintain the quality and effectiveness of data management processes within the function
  • Reviewed and processed clinical trial data to ensure the accuracy and consistency of clinical trial database
  • Performed other ad hoc queries.
  • Collaborated closely with physicians and nursing staff to improve quality of patient records documentation.
  • Implemented new coding and billing procedures that helped alleviate number of denied claims from insurance carriers.
  • Upheld critical security standards when managing user access actions such as setting up and removing accounts.
  • Worked with programming to coordinate Study Data Tabulation Model maps.
  • Drove operational improvements which resulted in savings and improved profit margins.
  • Received and processed stock into inventory management system.
Links Integrated - NY Drive Tester
City, STATE, 11/2011 - 12/2012
  • Entered numerical data into databases with speed and accuracy using 10-key pad.
  • Scanned documents and saved in database to keep records of essential organizational information.
  • Evaluated source documents to locate needed information.
  • Produced monthly reports with advanced Excel spreadsheet functions.
  • Maintained files, records and chronologies of entry activities.
  • Coded and processed applications into required electronic formats.
  • Completed data entry tasks with accuracy and efficiency.
  • Searched, extracted and interpreted information to determine correct input procedure.
  • Compiled and verified accuracy and sorting information to prepare source data for computer entry.
  • Kept optimal quality levels to prevent critical errors and support team performance targets.
  • Managed documents by organizing forms, making photocopies, filing records, preparing correspondence and creating reports.
  • Increased data-entry productivity by maintaining detailed logs of data projects, identifying issues and improving them.
  • Organized, sorted and checked input data against original documents.
  • Reviewed completed work for compliance with regulations.
  • Monitored database updates and verified for correctness.
  • Corrected data entry errors to prevent duplication or data degradation.
  • Sent completed entries for evaluation and final approval.

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Resume Overview

School Attended

  • Lagos State University

Job Titles Held:

  • Clinical Data Manager
  • Clinical Data Manager
  • NY Drive Tester

Degrees

  • Certificate in Pharmacy Tech
  • Bachelor of Science

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