Remote Clinical Data Manager

About the Role

Our client is seeking a highly skilled and experienced Clinical Data Manager to join their growing team in a fully remote position. This role is crucial for the successful execution of clinical trials, ensuring the integrity, accuracy, and quality of data collected. You will oversee the entire data management lifecycle, from database design and build to data validation, cleaning, and database lock.

The ideal candidate possesses a deep understanding of clinical trial processes, data standards (e.g., CDISC), and data management software, and excels in a remote work environment . This is an excellent opportunity to contribute to life-saving research within the pharmaceutical industry from anywhere in South Africa .

• Manage the clinical database build, edit checks, and data validation process according to protocol requirements and data management plans.
• Oversee data cleaning activities, query resolution, and ensure the timely completion of data management tasks.
• Ensure compliance with Good Clinical Practice (GCP), relevant regulatory requirements, and company SOPs.
• Collaborate closely with clinical operations, biostatistics, programming, and site personnel to ensure data quality and consistency.
• Develop and maintain data management documentation, including data management plans (DMPs) and database specifications.
• Lead User Acceptance Testing (UAT) for clinical databases and ensure successful database lock and archival.

• Bachelor's degree in a life science, computer science, statistics, or a related field.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotech industry.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Inform).
• Strong understanding of CDISC standards (SDTM, ADaM) and their implementation.
• Excellent understanding of clinical trial processes and regulatory requirements (GCP).
• Exceptional organizational skills, meticulous attention to detail, and the ability to work independently in a remote setting .

• Competitive annual salary with bonus potential.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• Opportunities for professional development, including access to training and conferences.
• A flexible, remote work arrangement allowing for a great work-life balance within the pharmaceutical research sector.