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,
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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