Senior Clinical Data Manager

Placements24; Soweto; Hybride; ZAR 900 000 - 1 300 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

EDC systems

Data management

Regulatory knowledge

CDISC standards

GCP compliance

Formation

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

Outils

Medidata Rave

Oracle Clinical

Description du poste

Our client, a reputable Contract Research Organization (CRO) at the forefront of clinical research, is seeking a detail-oriented and experienced Senior Clinical Data Manager to join their team in Soweto, Gauteng . This critical role is responsible for the management and quality control of clinical trial data from multiple sites, ensuring its accuracy, completeness, and integrity for regulatory submissions. The ideal candidate will possess extensive experience in clinical data management systems, EDC expertise, and a thorough understanding of clinical trial processes and regulatory guidelines. This is an excellent opportunity to contribute to the successful execution of clinical studies and play a key part in the advancement of new therapies within the Soweto community. You will ensure data is reliable for crucial medical decisions.

Key Responsibilities

• 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 .

Requirements

• 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 .

Benefits

• Our client offers a competitive salary, comprehensive benefits package including health, dental, and vision insurance, as well as a retirement savings plan.
• Opportunities for professional growth, continuous learning, and career advancement are readily available.
• You will join a collaborative and supportive work environment focused on delivering high-quality clinical research services.
• The company values work-life balance and provides generous paid time off.
• Be an integral part of advancing medical research and patient care from our Soweto operations.