Senior Clinical Data Associate – FSP

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

📋 Description

• Lead a small clinical trial or co-lead larger studies with moderate supervision.

• Provide support for multiple clinical trials while maintaining high standards of data quality and delivery.

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

• Review study protocols and assess data capture needs, including the design of eCRFs.

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

• Create specifications for data edit checks and produce listings of study data.

• Coordinate the design, testing, and resolution of issues related to Electronic Data Capture systems.

• Develop and maintain Data Management Plans for studies along with necessary documentation.

• Handle query management, external data reconciliations, and reconciliation of Serious Adverse Events.

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

• 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 across Phase I-IV clinical studies.

⛳️ Requirements

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

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

• Experience in clinical research and in regulated environments of the pharmaceutical or biotechnology industry.

• Knowledge of Phase I-IV clinical studies.

• Proven capability 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.

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

• Experience in Oncology or CNS therapeutic areas is preferred.

• Previous involvement in supporting Phase III pivotal studies is preferred.

• Strong preference for candidates with RAVE experience.

🏝️ Benefits

• Medical Aid Contribution

• Gap Cover

• Life Assurance

• Provident Fund (8%)

• 13th Cheque

• Flexibility

• Growth opportunities