Clinical Data Manager I

Roswell Park Comprehensive Cancer Center
124d$63,361

About The Position

The Clinical Data Manager I coordinates data management activities for investigator-initiated clinical trials from database design through delivery to Biostatistics for analysis. This role involves interpreting the study protocol and developing detailed database specifications, building forms and calendars in the current application, and ensuring appropriate structure, organization, content, and on-line instruction. The manager programs on-line logic constraints to control form behavior and prevent data entry errors, maintains data collection definitions, and documents data entry guidelines to facilitate consistency of data. Additionally, they set up data review plans, develop data edit check routines, review data for missing and incongruent data, perform patient data reconciliation between systems, and utilize a query management system to facilitate data resolution and clean-up. The manager monitors the progress of study data, assesses for analysis milestones, and releases data to the Biostatistician for analysis. They also serve as the gatekeeper for personnel access to clinical trial data and train all internal and external data entry personnel in database functionality and navigation capabilities.

Requirements

  • Bachelor’s degree in a science or medical field and one (1) year of full-time clinical data management experience; or
  • Associate’s degree in a science or medical field and three (3) years of full-time clinical data management experience.
  • Required degrees must have been granted by an accredited college or university or recognized by Roswell Park Comprehensive Cancer Center.

Responsibilities

  • Coordinates data management activities for investigator-initiated clinical trials.
  • Interprets study protocol and develops detailed database specifications.
  • Builds forms and calendars in the current application.
  • Ensures appropriate structure, organization, content, and on-line instruction.
  • Programs on-line logic constraints to control form behavior and prevent data entry errors.
  • Maintains data collection definitions.
  • Documents data entry guidelines to facilitate consistency of data.
  • Sets up data review plans and develops data edit check routines.
  • Reviews data for missing and incongruent data.
  • Performs patient data reconciliation between systems.
  • Utilizes a query management system to facilitate data resolution and clean-up.
  • Monitors the progress of study data and assesses for analysis milestones.
  • Releases data to Biostatistician for analysis.
  • Serves as gatekeeper for personnel access to clinical trial data.
  • Trains internal and external data entry personnel in database functionality and navigation capabilities.
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