Remote job
Clinical Data Associate II - South Africa (Remote) - FSP
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About this role
Role overview
Coordinate clinical data management activities for global Phase I–IV studies, supporting accurate data collection, review, reconciliation, and database delivery. The role works across clinical, statistical, programming, and study management functions, with responsibility for study tasks and vendor coordination. It is remote in South Africa and supports programs for a dedicated sponsor.
Responsibilities - Lead a small study or co-lead a larger one with moderate guidance, while contributing to several studies when needed. - Review protocols and data capture requirements, including electronic case report forms and completion instructions. - Coordinate EDC setup, testing, and issue resolution; prepare edit check specifications and data listings. - Maintain data management plans and study records, and help keep files ready for inspection. - Manage data queries and reconcile external datasets and serious adverse event information. - Assist with database upgrades, migrations, user acceptance testing, freezes, and locks; monitor vendor activities. - Collaborate with clinical research associates, programmers, statisticians, and study managers, and help improve procedures and work instructions.
Requirements - Bachelor’s degree in a scientific or healthcare-related field. - At least two years of pharmaceutical or biotechnology data management experience. - Understanding of Phase I–IV studies, core data management activities, and vendor coordination. - 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 skills, communication, and problem-solving ability.
Nice to have Oncology or CNS 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.