Clinical Data Manager
About the Role
Our client is seeking a skilled and organized Clinical Data Manager to join their hybrid team, supporting clinical research operations in the Soweto, Gauteng area. This role is essential for ensuring the accuracy, completeness, and consistency of clinical trial data, which is critical for regulatory submissions and scientific integrity. You will be responsible for overseeing the entire data management lifecycle, from database design and data collection to data cleaning and database lock. This hybrid position offers a flexible combination of remote data review and essential on-site team collaboration and oversight.
Key Responsibilities Oversee the design, development, and maintenance of clinical databases using EDC systems. Develop data management plans (DMPs) and data validation guidelines. Oversee data cleaning activities, including query generation and resolution, to ensure data accuracy and integrity. Manage clinical data collection processes, ensuring compliance with study protocols and regulatory standards (e.g., GCP, CDISC). Plan and execute database lock activities upon completion of data cleaning. Collaborate with clinical operations, biostatistics, and programming teams to ensure timely and high-quality data delivery. Requirements Bachelor's degree in a life science, computer science, statistics, or a related field. Minimum of 4 years of experience in clinical data management. Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical). Solid understanding of GCP, ICH guidelines, and data management best practices. Experience with data standards such as CDISC (SDTM, CDASH). Strong organizational skills, attention to detail, and problem-solving abilities. Benefits Competitive annual salary with performance-based bonuses. Comprehensive health, dental, and vision insurance plans. Opportunities for professional development and certification in data management. Hybrid work model providing flexibility between remote and on-site work. Contribution to groundbreaking pharmaceutical research and development efforts.