Senior Clinical Data Associate - Remote

Huzzle.Com; South Africa; Remote; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Medical Aid Contribution

Gap Cover

Life Assurance

Provident Fund (8%)

13th Cheque

Job summary

Parexel in South Africa is seeking a Senior Clinical Data Associate to join our team in a remote capacity. You will support global clinical research programs by delivering high-quality data management activities across Phase I-IV studies, ensuring data quality and regulatory compliance.

Responsibilities include leading studies, coordinating with CROs and vendors, developing annotated eCRFs, and maintaining Data Management Plans. Strong communication and problem-solving skills are essential.

Qualifications

• Bachelor's Degree in a scientific or healthcare-related field.
• At least five 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.

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.

Skills

Attention to detail

Analytical thinking

Organizational skills

Team collaboration

EDC systems experience

Data management

Regulatory compliance

Education

Bachelor's Degree in Life Sciences or Healthcare

Tools

RAVE EDC

Clinical data management software

Job description

Parexel in South Africa is seeking a Senior Clinical Data Associate to join our team in a remote capacity. You will support global clinical research programs by delivering high-quality data management activities across Phase I-IV studies, ensuring data quality and regulatory compliance.

Responsibilities include leading studies, coordinating with CROs and vendors, developing annotated eCRFs, and maintaining Data Management Plans. Strong communication and problem-solving skills are essential.