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Clinical Data Manager – Remote (South Africa)

Parexel

Remote
Remote 🇬🇧 English
RAVE Electronic Data Capture (EDC) User Acceptance Testing Serious Adverse Event reconciliation

Job description

About the role

We are looking for a Clinical Data Manager to join Parexel’s Functional Service Provider (FSP) team, working remotely from South Africa. The role supports a single sponsor’s commercial and development projects across phases I‑IV, ensuring high‑quality data capture and management throughout the study lifecycle.

Key responsibilities

  • Lead or co‑lead clinical studies, managing data management activities with minimal guidance.
  • Design and review electronic case report forms (eCRF) and develop annotated eCRF and completion guidelines.
  • Develop data edit check specifications, run data listings, and resolve EDC system issues.
  • Create and maintain the Data Management Plan, study workbooks, and data management files.
  • Enter, track, and resolve data queries in the EDC system; perform data reconciliation, including Serious Adverse Event reconciliation.
  • Coordinate EDC system design, testing, and user acceptance testing; support database upgrades and migrations.
  • Execute database lock and freeze activities according to SOPs.
  • Collaborate with CROs, vendors, CRAs, programmers, statisticians, and other cross‑functional team members.

Required profile

  • Strong knowledge of the clinical data management process and ability to work independently.
  • Experience designing eCRFs and managing EDC systems, preferably with RAVE.
  • Ability to lead small studies or co‑lead larger studies and support multiple studies simultaneously.
  • Excellent attention to detail and ability to follow SOPs and regulatory guidelines.

Required skills

  • RAVE (or comparable EDC platform)
  • Electronic Data Capture (EDC) system configuration and testing
  • eCRF design and annotation
  • Data edit check development
  • Database lock/freeze procedures
  • User Acceptance Testing (UAT)
  • Data query entry and resolution
  • Serious Adverse Event (SAE) reconciliation

What we offer

  • Long‑term job security within a global CRO network.
  • Opportunities to work on innovative phase I‑IV studies for leading biotech and pharma sponsors.
  • Fully remote, home‑based work arrangement.

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Published 1 month ago

Expires 6 days from now

46 views · 0 interested

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