Clinical Data Associate II – FSP

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Take the lead on a small clinical study or co-lead larger studies with moderate oversight.

• Assist in multiple clinical studies while ensuring adherence to high standards of data quality and delivery.

• Oversee and monitor data management activities conducted by CROs and external vendors.

• Evaluate study protocols and assess data capture needs, including eCRF design.

• Collaborate with CRAs, programmers, study managers, and statisticians to create annotated eCRFs and CRF completion guidelines.

• Formulate data edit check specifications and produce study data listings.

• Coordinate the design, testing, and troubleshooting of Electronic Data Capture systems.

• Develop and sustain study Data Management Plans and relevant documentation.

• Execute query management, external data reconciliations, and Serious Adverse Event reconciliation tasks.

• Assist with database upgrades, migrations, user acceptance testing, database freeze procedures, and database lock tasks.

• Keep study workbooks and data management files organized while ensuring readiness for inspections.

• Contribute to the creation and enhancement of data management SOPs, work instructions, and process documentation.

• Support global clinical research initiatives spanning Phase I-IV clinical studies.

• Collaborate with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to guarantee precise and timely data activities.

⛳️ Requirements

• A Bachelor’s Degree in a scientific or healthcare-related discipline.

• A minimum of two years' experience in Data Management within the pharmaceutical or biotechnology sector.

• Familiarity with Phase I-IV clinical studies.

• Proven ability to execute core Data Management tasks and liaise with vendors.

• Knowledge of ICH/FDA guidelines, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and associated industry standards.

• Experience with Electronic Data Capture systems and clinical data management technologies.

• Excellent communication, organizational, technical, and problem-solving abilities.

• Background in clinical research and regulated pharmaceutical or biotechnology settings.

• Ability to work effectively in multidisciplinary teams and in partnership with external stakeholders and vendors.

• Experience in Oncology or CNS therapeutic areas is preferred.

• Experience in supporting Phase III pivotal studies is preferred.

• RAVE experience is strongly preferred.

🏝️ Benefits

• Medical Aid Contribution

• Gap Cover

• Life Assurance

• Provident Fund (8%)

• 13th Cheque

• Flexibility

• Growth opportunities