Senior Clinical Data Specialist – Remote (SA)

Placements24; Klerksdorp; Remote; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Medical Aid Contribution

Gap Cover

Life Assurance

Provident Fund (8%)

13th Cheque

Zusammenfassung

Parexel is seeking a Senior Clinical Data Associate to join our team in South Africa on a remote basis. You will support global clinical studies from Phase I–IV, driving data quality, regulatory compliance, and study deliverables across CROs and vendors.

You will lead data management activities, coordinate EDC systems, develop study documentation, and contribute to database locks, listings, and inspection readiness in a fast-paced sponsor environment.

Qualifikationen

• Bachelor's Degree in a scientific or healthcare-related field.
• At least five years' experience in Data Management within the pharmaceutical/biotech industry.
• Understanding of 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 EDC systems; RAVE experience strongly preferred.
• Strong communication, organization, technical, and problem-solving skills.

Aufgaben

• Lead a clinical study or co-lead larger studies with moderate guidance.
• Support multiple studies ensuring high data quality and timely delivery.
• Manage data management activities performed by CROs and vendors.
• Review protocols and data capture requirements, including eCRF design.
• Collaborate with CRAs, programmers, statisticians to develop annotated eCRFs.
• Develop data edit check specifications and study data listings.
• Coordinate EDC system design, testing and issue resolution.
• Maintain Data Management Plans and supporting documentation.
• Perform query management, data reconciliations, and SAE reconciliation.
• Support database upgrades, migrations, testing, and database lock activities.
• Maintain study workbooks and ensure inspection readiness.
• Contribute to SOPs and process documentation improvements.

Kenntnisse

Attention to detail

Analytical thinking

Organizational skills

Communication skills

Team collaboration

Ausbildung

Bachelor's Degree in a scientific or healthcare-related field

Tools

Electronic Data Capture (EDC) systems

RAVE

Jobbeschreibung

Parexel is seeking a Senior Clinical Data Associate to join our team in South Africa on a remote basis. You will support global clinical studies from Phase I–IV, driving data quality, regulatory compliance, and study deliverables across CROs and vendors.

You will lead data management activities, coordinate EDC systems, develop study documentation, and contribute to database locks, listings, and inspection readiness in a fast-paced sponsor environment.