Category

Description

Specific Tasks Would Include

• • Reads and follows the Data Management Plan (DMP) for ongoing projects.
  • Assists in / coordinates CRF/Data Clarification Form (DCF) tracking, if applicable for the project.
  • May perform Quality Control (QC) activities related to database open.
  • May create test subjects for edit check validation and database export QC.
  • May provide appropriate personnel with the data conventions and guidelines for each specific project, ensures understanding and remains a resource throughout the project.
  • May perform data entry and/or verification tasks as necessary for assigned projects.
  • Addresses all issues relative to the clinical database with the Data Manager.
  • Reviews data, writes, resolves and modifies data discrepancies/queries.
  • Generates, formats, and edits data discrepancy reports.
  • May send queries to sites, Sponsor, and monitors, and communicate as necessary to help resolve queries.
  • Updates the clinical database following the query and resolution process.
  • May communicate with the Sponsor as needed regarding data/database issues, as directed by Data Manager or Data Management Oversight
  • May respond to requests or needs of the Sponsor during the course of the project, as directed by Data Manager or Data Management Oversight.
  • Learns sufficient SAS programming to produce simple reports. May use SAS to review clinical datasets.
  • Produces reports, listings, and other output as required during the course of the project.
  • May export data from the clinical database to update the SAS database.
  • May assist in the creation of subject profiles to check data points against paper CRFs as part of the final database QC.
  • May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.
  • May assist in maintaining project documentation.
  • May assist in coordinating activities related to final database closure.
  • Performs final Quality Control check of profiled clinical data against paper CRFs.
  • May assist with training end users on the applicable Clinical Data Management System, maintaining current system access and ensuring all training records are up to date.
  • May archive or assist in the archival of project documents.
  • May perform coding of medical terms/medications.
  • May provide operational and technical guidance and direction to colleagues.

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