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Clinical Data Management Lead

2 weeks ago

Centurion, Gauteng, South Africa IQVIA Full time

Job Summary

We are seeking a highly skilled and experienced Clinical Data Management Lead to join our team at IQVIA.

About the Role

The successful candidate will be responsible for providing data management support, oversight, and accountability for one or more clinical trials. They will take the lead with trial customers and other internal and external partners to establish, align, and confirm data management expectations.

Key Responsibilities

  • Creating, planning, and tracking content, format, quality, and timing of data management deliverables, including CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan, and archival.
  • Gathering content and integration requirements for eCRF and other data collection tools.
  • Establishing conventions and quality expectations for clinical data.
  • Establishing expectations for dataset content and structure.
  • Setting timelines and follow-up to ensure delivery of all Data Management milestones.
  • Performing trial-level oversight controls, as appropriate, as described in the oversight plan, QC process, and work instructions with minimal DML direction.
  • Creating clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensuring compliance with regulatory guidelines and the documentation matrix.
  • Ensuring real-time inspection readiness of all Data Management deliverables for the trial; Participating in Regulatory Agency and audits, as necessary.