Principal Clinical Database Programmer

4 weeks ago

India Veramed Full time

Title: Principal Database and Validation, Analytical Programmer

Purpose:

The database programmer is responsible for the programming and set up of the electronic data capture (EDC) system, plus any other contracted modules of the software (e.g. PRO or RTSM). The database programmer will also create validation and analytical outputs outside of EDC.

Key Responsibilities

  • Develop and program EDC databases accordingly to the study protocol with quality and efficiency to support the conduct of clinical trials.
  • Develop and program other modules such ePRO, eSource, RTSM, etc. used for collection of clinical trial data.
  • Program the edit checks in the EDC system.
  • Program complex checks, such as custom functions
  • Lead the study database design, edit checks programming, study deployment and study maintenance of clinical trial databases.
  • Provide technical expertise to the team members in the areas of clinical database design and programming.
  • Perform review, and QC of databases before UAT and Production releases as appropriate.
  • Test and evaluate new technologies and upgrades to technologies to ensure minimal impact on Clinical Operations stakeholders.
  • Create data validation listings/outputs outside of the EDC
  • Create data analytical outputs, supporting risk identification (KRI) and critical to quality factors. The outputs should be in the form of graphical/visual outputs whenever possible
  • Create protocol deviations (that are identifiable through the data) outputs and trending reports
  • Create ad-hoc listings/reports to support Data Management and other clinical areas for data cleaning, data reviewing, and trial monitoring functions.
  • At a minimum data status reports should include, missing pages, missing visits, SDV, data review status, queries again. Reports should show trending overtime to allow for data insights
  • Collaborate with Data Management personnel to develop data specifications and come up with the best solutions for the technology being used.
  • Take a lead role in performing and maintaining the Computer Software Validation (CSV) testing and Maintenance
  • Perform and support internal staff training, trial deployment, post-production/study modification changes, trial archival/submission.
  • Independently and collaboratively bring project database or reporting solutions to the project teams.
  • Develop, revise, and maintain core operating procedures, templates and working instructions.
  • Meet milestones as assigned, and interact with project teams to organise timelines, responsibilities, and deliverables.
  • Perform other related duties as assigned to meet the goals and objectives of the department.

Minimum Qualification Requirements

  • B.S. in a Computer Science or related field.
  • Minimum of 7 years' experience developing database applications for clinical trials
  • Medidata Certified

Other Information/Additional Requirements

  • Attention to detail.
  • Ability to work in a team environment.
  • Ability to meet and drive deadlines.
  • Strong communication skills both written and verbal.

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