Senior Clinical Data Associate – FSP

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

📋 Description

• Oversee a small clinical study or assist in leading larger studies with moderate supervision.

• Support various clinical studies while upholding high standards for data quality and timely delivery.

• Manage and oversee data management tasks carried out by CROs and external vendors.

• Review study protocols and assess data capture needs, including the design of electronic Case Report Forms (eCRF).

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

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

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

• Create and maintain study Data Management Plans and related documentation.

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

• Assist with database upgrades, migrations, user acceptance testing, database freeze activities, and database locking processes.

• Keep study workbooks and data management files updated, ensuring readiness for inspections.

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

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

⛳️ Requirements

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

• Minimum five years of experience in Data Management within the pharmaceutical or biotechnology sector.

• Experience in clinical research and within regulated pharmaceutical or biotechnology settings.

• Knowledge of Phase I-IV clinical studies.

• Proven ability to execute essential Data Management tasks and collaborate with vendors.

• Familiarity with ICH/FDA guidelines, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and other relevant industry standards.

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

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

• Preferred experience in Oncology or CNS therapeutic areas.

• Preferred experience supporting Phase III pivotal studies.

• RAVE experience is strongly preferred.

🏝️ Benefits

• Medical Aid Contribution

• Gap Cover

• Life Assurance

• Provident Fund (8%)

• 13th Cheque

• Flexible work arrangements

• Growth opportunities

• Opportunity to broaden expertise across data management processes, clinical technologies, and cross-functional study operations