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clinical data associate ii resume example with 3+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
  • :
Summary

Dedicated and passionate data manager with experience in sponsor dedicated database maintenance. Seeking an opportunity to continue to gain knowledge within a CRO in order to grow within data management.

Skills
  • Ability to work well as a valuable member of a team
  • Proven ability to manage time effectively in order to meet deadlines
  • Proficient in Microsoft Office with a focus in Microsoft Excel
  • Proficient in various job specific data management systems such as iMedidata - Rave and Veeva Vault TMF
  • Up-to-date knowledge of FDA and ICH-GCP guidelines
  • Excellent attention to detail and ability to pick up on errors in data
  • Proficient in the following areas of data management:

Data Cleaning

Vendor Reconciliation

Data Review

Query Writing

SAE Reconciliation

CRF Design

User Acceptance Testing

Experience
Clinical Data Associate II, 01/2021 to 10/2022
SpreetailPennsylvania, AL,
  • Maintained awareness of the pertinent elements of contract and scope of work for assigned project(s)

  • Reviewed and adhered to the requirements of study-specific Clinical Data Management Plans for assigned project(s)

  • Created and entered test data for User Acceptance Testing (UAT)

  • Performed User Acceptance Testing (UAT) for data entry screens, edits and assigned data review listings

  • Received and entered lab normal ranges

  • Performed reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database
  • Performed DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems

  • Participated in internal meetings and internal/external audits as required

  • Filed documentation in the Data Management Study

  • Maintained proficiency in Data Management systems and processes through regular training
  • Coordinated the work of CDAs assigned to the project
  • Provided training on data management activities and systems

  • Ensured that data from external databases/datasets are consistent with data in the clinical database
  • Used the specified process to document and query any such discrepancies found with the appropriate party

  • Completed tasks within a timeframe by appropriately prioritizing multiple tasks within or across projects and adapted to timeline or priority changes by reorganizing daily workload
  • Proactively communicated to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts
  • Minimized rework by following study instructions, seeking understanding of assignments prior to performing tasks and anticipating the effect changes may have on data when issuing and resolving queries

  • Ran data cleaning and/or status reports

  • Performed Serious Adverse Event (SAE) reconciliations
  • Performed post-migration testing on screens, edit checks, matrices and role changes as required
  • Provided input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance
Data Management Intern, 01/2020 to 05/2020
Department Of DefensePineville, LA,
  • Maintained awareness of the pertinent elements of contract and scope of work for assigned project(s)
  • Reviewed and adhered to the requirements of study-specific Clinical Data Management Plans for assigned project(s)
  • Generated and entered test data for user acceptance testing under guidance
  • Completed and submitted Clinical Database Management System-specific access forms and/or spreadsheets
  • Performed review of discrepancy (edit check) output and validation listings based on data entered into the clinical database
  • Resolved answered queries correctly and re-queries where appropriate
  • Performed DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems
  • Ran data cleaning and/or status reports
  • Participated in internal meetings and in internal/external audits as required
  • Filed documentation the Data Management Study File
  • Maintained proficiency in DM systems and processes through regular training courses
Pharmacy Technician, 08/2018 to 05/2020
WalgreensCity, STATE,
  • Received written prescription or refill requests and verify that information is complete and accurate
  • Entered data accurately from written and electronic prescriptions
  • Answered telephones, responding to questions or requests
  • Filled bottles with prescribed medications, and typed and affixed labels
  • Ordered, labeled, and counted stock of medications, chemicals, or supplies and entered inventory data into the computer
  • Prepared and processed medical insurance claim forms and records
Education and Training
Bachelor of Science: Clinical Research, Expected in 05/2020 to Campbell University - Buies Creek, NC
GPA:
  • Clinical Research Outstanding Academic Performance Award Recipient
  • Graduated magna cum laude
Additional Information
  • HONORS & ACTIVITIES , Clinical Research Outstanding Academic Performance Award - Campbell University (2020) on new assignments and resourcing conflicts

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Resume Overview

School Attended

  • Campbell University

Job Titles Held:

  • Clinical Data Associate II
  • Data Management Intern
  • Pharmacy Technician

Degrees

  • Bachelor of Science

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