Senior Clinical Data Manager — EDC & Data Quality Lead

Placements24; Soweto; Hybrid; ZAR 900.000 - 1.300.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Zusammenfassung

Placements24 in Soweto, Gauteng, is seeking a Senior Clinical Data Manager to oversee end-to-end data management for clinical trials, ensuring data accuracy, integrity and regulatory compliance across sites.

The role requires 5+ years in clinical data management, hands-on EDC experience (Medidata Rave, Oracle Clinical), plus CDISC, ICH GCP knowledge, with a collaborative, detail-driven approach and ability to manage multiple studies.

Qualifikationen

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical) and data management software.
• Strong understanding of clinical trial processes, CDISC standards, and ICH GCP guidelines.
• Experience in developing DMPs, edit checks, and data validation plans.
• Excellent analytical and problem-solving skills.
• Meticulous attention to detail and a commitment to data accuracy.
• Effective written and verbal communication skills.
• Ability to work independently and manage multiple projects concurrently.
• Prior experience with database lock activities is highly preferred for this role in Soweto.

Aufgaben

• Oversee the end-to-end clinical data management process for assigned studies.
• Develop and manage Data Management Plans (DMPs), including database design, edit check specifications, and data validation procedures.
• Perform data cleaning activities, resolving discrepancies and inconsistencies in a timely manner.
• Validate data entry and ensure compliance with protocol and regulatory requirements.
• Collaborate with Clinical Operations, Biostatistics, and Statistical Programming teams to ensure data quality and timely database lock.
• Provide training and guidance to junior data management staff.
• Manage User Acceptance Testing (UAT) for clinical databases and related systems.
• Contribute to the development and maintenance of standard operating procedures (SOPs) for data management.
• Ensure compliance with ICH GCP guidelines and all applicable regulatory requirements.
• Maintain a high standard of data quality and integrity throughout the clinical trial lifecycle in Soweto.

Kenntnisse

EDC systems

Data management

Regulatory knowledge

CDISC standards

GCP compliance

Ausbildung

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

Tools

Medidata Rave

Oracle Clinical

Jobbeschreibung

Placements24 in Soweto, Gauteng, is seeking a Senior Clinical Data Manager to oversee end-to-end data management for clinical trials, ensuring data accuracy, integrity and regulatory compliance across sites.

The role requires 5+ years in clinical data management, hands-on EDC experience (Medidata Rave, Oracle Clinical), plus CDISC, ICH GCP knowledge, with a collaborative, detail-driven approach and ability to manage multiple studies.