Remote Clinical Data Associate II (South Africa)

Parexel; South Africa; Remote; ZAR 279.000 - 446.000; Vollzeit

Benefits dieser Stelle

Medical Aid Contribution

Gap Cover

Life Assurance

Provident Fund (8%)

13th Cheque

Zusammenfassung

Parexel is seeking a Clinical Data Associate II to join our team in South Africa in a remote capacity. You will support global clinical research programs by delivering high-quality data management activities across Phase I-IV studies, collaborating with clinical teams and vendors to ensure accurate data collection and timely deliverables.

You will lead data management activities, coordinate EDC systems, and contribute to study documentation and database lock processes, while maintaining

Qualifikationen

• Bachelor's Degree in a scientific or healthcare-related field.
• Minimum 2 years Data Management experience in pharmaceutical/biotech.
• Experience with Electronic Data Capture systems; knowledge of CDISC, ICH/FDA, GCDMP.
• Familiarity with Phase I–IV studies; vendor engagement.
• Strong communication and problem-solving skills.

Aufgaben

• Lead a small clinical study or co-lead larger studies with moderate guidance.
• Support multiple studies ensuring high data quality and delivery.
• Manage data management activities by CROs and external vendors.
• Review study protocols and evaluate data capture requirements, including eCRF design.
• Collaborate with CRAs, programmers, study managers, and statisticians to develop annotated eCRFs and CRF completion guidelines.
• Develop data edit check specifications and generate study data listings as required.
• Coordinate the design, testing, and issue resolution of EDC systems in accordance with company standards.
• Develop and maintain study Data Management Plans and supporting documentation
• Perform query management, external data reconciliations, and Serious Adverse Event reconciliation activities.
• Support database upgrades, migrations, user acceptance testing, database freeze activities, and database lock activities.
• Maintain study workbooks and data management files while ensuring inspection readiness.
• Contribute to the development and improvement of data management SOPs, work instructions, and process documentation.

Kenntnisse

Attention to detail

Analytical thinking

Strong communication

Team collaboration

Ausbildung

Bachelor's degree in a science/healthcare field

Tools

RAVE

Jobbeschreibung

Parexel is seeking a Clinical Data Associate II to join our team in South Africa in a remote capacity. You will support global clinical research programs by delivering high-quality data management activities across Phase I-IV studies, collaborating with clinical teams and vendors to ensure accurate data collection and timely deliverables.

You will lead data management activities, coordinate EDC systems, and contribute to study documentation and database lock processes, while maintaining