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Clinical Data Management Director

1 week ago

Durban, KwaZulu-Natal, South Africa IQVIA Full time

**Job Description for Clinical Data Management Director at IQVIA**

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.

**Key Responsibilities**
  • Provides data management support, oversight, and/or accountability for one or more clinical trials.
  • Takes the lead with trial customers and other internal and external partners to establish, align, and confirm data management expectations.
  • Creates, plans, and tracks 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.
  • Gathers content and integration requirements for eCRF and other data collection tools in collaboration with trial customers and functional partners.
  • Establishes conventions and quality expectations for clinical data.
  • Defines expectations for dataset content and structure.
  • Sets timelines and follows up to ensure delivery of all Data Management milestones.
  • Performs trial-level oversight controls, as appropriate, as described in the oversight plan, QC process, and work instructions with minimal DML direction.
  • Develops clinical data management documents (including submission packages) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
  • Ensures real-time inspection readiness of all Data Management deliverables for the trial; participates in Regulatory Agency and audits as necessary.
  • Collaborates in planning, creating, and tracking content, format, quality, and timing of data management deliverables.
  • Ensures deliverables are on time.
  • Participates in assigned clinical working groups to ensure that Data Management and Therapeutic Area trial needs and deliverables are met.
  • Helps identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
  • Presents and trains at investigator and monitor meetings.
**Required Skills and Qualifications**
  • Bachelor's degree or higher preferably in Health Sciences, or Bachelor's degree or higher with professional clinical experience/exposure.
  • At least 4 years of Data Management experience.
  • Vendor Management experience.
  • Rave experience.

This role is not eligible for UK visa sponsorship.