IQVIA

Senior Clinical Database Designer

IQVIA

full-time

Posted on:

Location Type: Office

Location: Thane • 🇮🇳 India

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Job Level

Senior

About the role

  • Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components.
  • Collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives.
  • Responsible for the project financials from programming shared services perspective.
  • Interprets the study protocol.
  • Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable.
  • Create and update Edit Specification Document.
  • Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)
  • Complete the Study Authorization Form and Trial Capacity Request Form (InForm)
  • 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.
  • Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates.
  • 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 QIP for own projects, identify out of scope activities if any and inform relevant parties.
  • Responsible for multiple study design projects at the same time.
  • 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.

Requirements

  • Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
  • 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs of Data Management experience. Req

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
study buildstudy designsystem configurationseCRF designEdit Specification DocumentEDC build componentsdatabase designdata managementprocess improvement
Soft skills
collaborationcommunicationleadershiprisk managementproblem-solvingorganizational skills
Certifications
Bachelor's Degree in ScienceBachelor's Degree in Computer ScienceBachelor's Degree in Information TechnologyBachelor's Degree in Technology