Sr Clinical DB Designer

2 - 5 years

6 - 10 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Design and update eCRF using third-party or in-house CDMS tools aligned with industry standards like SDTM and CDASH.
  • Create and update Edit Specification Documents and generate specifications for EDC build components.
  • Complete Study Authorization Forms and Trial Capacity Request Forms (InForm).
  • Attend Pre-Design Meetings, Online Screen Review Meetings, and Unblinded Data review meetings.
  • Lead Online Screen Review Meetings and facilitate internal Edit Specification Review Meetings.
  • Design databases to collect LLRR data within the InForm database and ensure appropriate access for entry and updates.
  • Communicate project risks to the Data Team Lead, including potential timeline misses in the Data Management Project Plan.
  • Escalate quality issues and document all project-specific training, staying current with required Standard Operating Procedures.
  • Review build timelines and provide input as applicable; review QIP for own projects, identify out-of-scope activities, and inform relevant parties.
  • Manage multiple study design projects simultaneously across various platforms.
  • Identify areas for process improvements and contribute to initiatives, providing suggestions for continuous process improvement.
  • Ensure completion and documentation of all project-specific training and stay current with required Standard Operating Procedures.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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Iqvia Biotech logo
Iqvia Biotech

Pharmaceuticals / Biotechnology

Nashville

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