Clinical Data Manager – Remote (South Africa)
Parexel
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
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