Senior Clinical Data Analyst (Home-based) - South Africa, Poland, Hungary or UK,- FSP

Job Location : , South Africa, South Africa

Application Deadline : February 09, 2026

Responsibilities

• Lead a large clinical study or a series of related studies with minimum guidance.
• Represents Data Management on the CTWG for assigned studies.
• Provide mentoring and training to lower-level Data Management staff assigned to your studies.
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Be able to perform a thoroughly detailed review of eCRF data requirements.
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Lead the development of data edit check specifications and data listings.
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.
• Develop or lead the development of the Data Management Plan for a clinical study.
• Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
• Provide training on the EDC system and / or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
• Perform reconciliation of header data from external data sources against the clinical database.
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.
• Lead database upgrades / migrations including performing User Acceptance Testing.
• Maintain study workbooks and data management files.
• Perform database lock and freeze activities per company SOPs.
• Participate in regular team meetings and provide input when appropriate.
• Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents.
• Contribute to a professional working environment including the application of the sponsor’s Code of Business Conduct and Ethics.
• Assist with the training of new employees and / or contractors.

Here are a few requirements specific to this advertised role.