Senior Clinical Data Manager - Remote, Global Trials

Parexel; South Africa; Remote; ZAR 700,000 - 950,000; Full time

Job summary

Parexel is seeking a Senior Clinical Data Associate to join our team in South Africa in a remote capacity. You will support global clinical programs by delivering high-quality data management across Phase I-IV studies, collaborating with clinical teams, statisticians, programmers, CRAs, vendors, and study management to ensure accurate data collection and timely database management.

You will lead data management activities, coordinate EDC systems, develop study documentation, and contribute to

Qualifications

• Bachelor's Degree in a scientific or healthcare-related field.
• At least five years of Data Management experience in pharma/biotech.
• Experience with Phase I–IV studies and data management activities with vendors.
• Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries.
• Experience with Electronic Data Capture systems; RAVE experience strongly preferred.
• Strong communication, organization, technical, and problem-solving skills.

Responsibilities

• Lead data management for clinical studies or co-lead larger studies with moderate guidance.
• Support multiple clinical studies while ensuring high data quality and timely delivery.
• Manage and monitor data management activities performed by CROs and external vendors.
• Review study protocols and evaluate data capture requirements, including eCRF design.
• Collaborate with CRAs, programmers, study managers, and statisticians to develop annotated eCRFs and CRF completion guidelines.
• Develop data edit check specifications and generate study data listings as required.
• Coordinate the design, testing, and issue resolution of EDC systems per company standards.
• Develop and maintain study Data Management Plans and supporting documentation.
• Perform query management, external data reconciliations, and SAE reconciliation activities.
• Support database upgrades, migrations, UAT, database freeze, and DB lock activities.
• Maintain study workbooks and data management files ensuring inspection readiness.
• Contribute to the development and improvement of data management SOPs and process documentation.

Skills

Attention to detail

Analytical thinking

Organizational skills

Cross-functional collaboration

Data quality

Regulatory compliance

Education

Bachelor's degree in a scientific field

Tools

RAVE

Job description

Parexel is seeking a Senior Clinical Data Associate to join our team in South Africa in a remote capacity. You will support global clinical programs by delivering high-quality data management across Phase I-IV studies, collaborating with clinical teams, statisticians, programmers, CRAs, vendors, and study management to ensure accurate data collection and timely database management.

You will lead data management activities, coordinate EDC systems, develop study documentation, and contribute to