Clinical Data Associate II - South Africa (Remote) - FSP at PAREXEL

About the Role

• We are seeking a Clinical Data Associate II to join our team in South Africa in a remote capacity.
• As a Clinical Data Associate II, you will support global clinical research programs by delivering high-quality data management activities across Phase I-IV clinical studies. This position plays a key role in clinical data quality, regulatory compliance, study execution, and cross-functional collaboration.
• You will partner with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to ensure accurate and timely data collection, review, reconciliation, and database management activities. Responsibilities include supporting and leading data management activities, coordinating Electronic Data Capture (EDC) systems, developing study documentation, and contributing to database lock and study deliverables.
• You will join a fast-paced, growth-oriented environment dedicated to a single sponsor and supporting important commercial and development programs worldwide.
• This role offers the opportunity to contribute directly to clinical research that advances new therapies while expanding your expertise across data management processes, clinical technologies, and cross-functional study operations.

Key Responsibilities

• Lead a small clinical study or co-lead larger studies with moderate guidance.
• Support multiple clinical studies while ensuring high standards of data quality and delivery.
• Manage and monitor data management activities performed by CROs and external vendors.
• Review study protocols and evaluate data capture requirements, including electronic Case Report Form (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 Electronic Data Capture systems in accordance with company standards.
• Develop and maintain study Data Management Plans and supporting documentation
• Perform query management, external data reconciliations, and Serious Adverse Event reconciliation activities.
• Support database upgrades, migrations, user acceptance testing, database freeze activities, and database lock activities.
• Maintain study workbooks and data management files while ensuring inspection readiness.
• Contribute to the development and improvement of data management SOPs, work instructions, and process documentation.

Candidate Profile

You'll thrive in this role if you bring:

• Strong attention to detail, analytical thinking, and organizational skills.
• Experience working within clinical research and regulated pharmaceutical or biotechnology environments.
• The ability to collaborate effectively across multidisciplinary teams as well as with external partners and vendors.
• A patient-focused mindset with a commitment to data quality and regulatory compliance.
• Comfort working with Electronic Data Capture systems, clinical databases, and multiple technology platforms.

Required Qualifications

• Bachelor's Degree in a scientific or healthcare-related field.
• At least two years' experience in Data Management within the pharmaceutical or biotechnology industry.
• Understanding of Phase I-IV clinical studies and demonstrated ability to perform core Data Management activities and work with vendors.
• Knowledge of ICH/FDA guidance, 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. RAVE experience is strongly preferred.
• Strong communication, organization, technical, and problem-solving skills.

Preferred Qualifications

• Experience in Oncology or CNS therapeutic areas.
• Experience supporting Phase III pivotal studies.

Benefits and Compensation

• Medical Aid Contribution
• Gap Cover
• Life Assurance
• Provident Fund (8%)
• 13th Cheque