Sr. Clinical DB Designer

IQVIA•Durham, NC

About The Position

Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective.

Requirements

  • Bachelor's Degree in Science/Computer science/Information Technology or Bachelor in Technology
  • 2-4 years of relevant RAVE designer experience
  • Total experience being 7+ years

Responsibilities

  • Interprets the study protocol.
  • Design and update the eCRF within Medidata RAVE and other platforms as required.
  • Create and update Edit Specification Document.
  • Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page).
  • Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting.
  • Attend and present comments at the Internal Design Review Meeting.
  • May lead Online Screen Review Meeting.
  • Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document.
  • Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan.
  • Escalate potential quality issues.
  • Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures.
  • Reviews build timelines and provide input as applicable.
  • Reviews budgets for own projects, identify out of scope activities if any and inform relevant parties.
  • Responsible for multiple study design projects at the same time.
  • Might be working on projects across multiple platforms.
  • Identify areas for process improvements on an ongoing basis.
  • Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes.

Benefits

  • health and welfare benefits
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