Senior Clinical Data Associate - South Africa (Remote) - FSP

Role overview

Support global Phase I–IV clinical studies by coordinating data management work from study setup through database lock. The role combines hands-on data review and documentation with oversight of external vendors and collaboration across clinical, statistical, programming, and study management teams. Work is remote in South Africa and supports programs for a dedicated sponsor.

Responsibilities - Lead a small study or co-lead larger studies with moderate guidance, while supporting multiple studies as needed. - Review protocols and data collection needs, including electronic case report form design and completion guidance. - Coordinate EDC design, testing, troubleshooting, and issue resolution; prepare edit check specifications and data listings. - Maintain data management plans, study files, workbooks, and inspection-ready documentation. - Manage queries and reconcile external data and serious adverse event information. - Support database upgrades, migrations, user acceptance testing, freezes, and locks; monitor vendor data management activities. - Work with clinical research associates, programmers, statisticians, and study managers, and contribute to process and procedure improvements.

Requirements - Bachelor’s degree in a scientific or healthcare-related discipline. - At least five years of pharmaceutical or biotechnology data management experience. - Familiarity with Phase I–IV trials, core data management activities, and vendor collaboration. - Knowledge of ICH/FDA guidance, CDISC, GCDMP, 21 CFR Part 11, MedDRA, and WHO Drug Dictionaries. - Experience with EDC systems and clinical data management technologies; RAVE experience is strongly preferred. - Strong attention to detail, analytical and organizational ability, communication, and problem-solving skills.

Nice to have Oncology or CNS study experience and experience supporting Phase III pivotal trials.

Benefits and work setup Remote role based in South Africa. Listed benefits include a medical aid contribution, gap cover, life assurance, an 8% provident fund contribution, and a 13th cheque.