Senior Clinical Data Associate – 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 overseeing larger studies with moderate guidance.

• Provide support for multiple clinical studies while upholding high standards for data quality and timely delivery.

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

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

• Collaborate with Clinical Research Associates (CRAs), programmers, study managers, and statisticians to create annotated eCRFs and guidelines for CRF completion.

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

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

• Develop and maintain Data Management Plans and related documentation for studies.

• Conduct query management, reconcile external data, and manage Serious Adverse Event reconciliation activities.

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

• Keep study workbooks and data management files up to date while ensuring readiness for inspection.

• Contribute to the formulation and enhancement of data management Standard Operating Procedures (SOPs), work instructions, and process documentation.

• Collaborate with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to guarantee accurate and timely data collection, review, reconciliation, and database management.

⛳️ Requirements

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

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

• Proven experience in clinical research and within regulated environments of the pharmaceutical or biotechnology industry.

• Familiarity with Phase I-IV clinical studies.

• Proven capability 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 related industry standards.

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

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

• Preferred experience in Oncology or CNS therapeutic areas.

• Preferred experience supporting Phase III pivotal studies.

• Strong preference for candidates with RAVE experience.

🏝️ Benefits

• Medical Aid Contribution.

• Gap Cover.

• Life Assurance.

• Provident Fund (8%).

• 13th Cheque.

• Flexibility.

• Growth opportunities.