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 assist in leading larger studies with moderate supervision.

• Oversee multiple clinical studies while ensuring exceptional standards of data quality and timely delivery.

• Manage and supervise data management tasks conducted by CROs and external vendors.

• Review study protocols and assess data capture requirements, 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 study data listings.

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

• Develop and uphold Data Management Plans and accompanying documentation for studies.

• Handle query management, external data reconciliations, and activities related to Serious Adverse Event reconciliation.

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

• Maintain study workbooks and data management files, ensuring they are inspection-ready.

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

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

⛳️ Requirements

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

• 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 essential Data Management tasks and collaborate with vendors.

• Knowledge of 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 technologies for clinical data management.

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

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

• Capability to work effectively with multidisciplinary teams and external partners and vendors.

• Experience in Oncology or CNS therapeutic areas is preferred.

• Experience 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

• Remote work arrangement