Senior Clinical Data Lead — Remote

Blacksmith Agency Llc; South Africa; A distancia; ZAR 900.000 - 1.300.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Aid Contribution

Gap Cover

Life Assurance

Provident Fund (8%)

13th Cheque

Descripción de la vacante

Parexel is seeking a Senior Clinical Data Associate to join our team in South Africa 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.

In this role you will collaborate with clinical teams, vendors, and study management to guarantee accurate data capture, review, reconciliation, and database management, contributing to study deliverables and

Formación

• At least five years' experience in Data Management within pharma/biotech.
• Understanding of Phase I-IV studies and data management with vendors.
• Knowledge of ICH/FDA guidance, CDISC, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries.
• Experience with Electronic Data Capture systems; RAVE preferred.
• Strong communication, organization, and problem-solving skills.

Responsabilidades

• Lead data management activities for clinical studies with moderate guidance.
• Coordinate data capture, edit checks, and data listings as required.
• Oversee data management activities by CROs and vendors.
• Develop annotated eCRFs and CRF completion guidelines with teams.
• Support database design, testing, and issue resolution per standards.
• Maintain study Data Management Plans and documentation.
• Ensure inspection readiness and timely study deliverables.

Conocimientos

Attention to detail

Analytical thinking

Organizational skills

Regulatory compliance

Communication skills

Educación

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

Herramientas

RAVE

Electronic Data Capture systems

Descripción del empleo

Parexel is seeking a Senior Clinical Data Associate to join our team in South Africa 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.

In this role you will collaborate with clinical teams, vendors, and study management to guarantee accurate data capture, review, reconciliation, and database management, contributing to study deliverables and