Clinical Data Manager

About the Role

Our client is seeking an experienced Clinical Data Manager to oversee the collection, cleaning, and management of clinical trial data in Nelspruit . This critical role ensures the integrity, accuracy, and completeness of data used for regulatory submissions and scientific analysis. You will lead data management activities throughout the trial lifecycle, from database design and validation to data review and final database lock. The ideal candidate possesses a strong understanding of clinical trial processes, data management systems, and relevant regulatory requirements, working collaboratively with statisticians, programmers, and clinical operations teams to ensure high-quality data outputs.

Key Responsibilities

• Develop and manage clinical databases, including Case Report Forms (CRFs) and edit checks.
• Oversee the data cleaning and validation process, resolving data queries in a timely manner.
• Ensure compliance with data management best practices, ICH-GCP, and regulatory guidelines.
• Participate in the design and review of clinical study protocols and statistical analysis plans.
• Generate data management reports and metrics for study progress and data quality.
• Collaborate with statisticians and programmers to ensure smooth data transfer and analysis.
• Contribute to the development and maintenance of data management SOPs and quality standards.

Requirements

• Bachelor's degree in a relevant scientific or healthcare field.
• Minimum of 5 years of experience in clinical data management .
• Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP).
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple projects simultaneously in a hybrid setting.

Benefits

• Competitive annual salary and performance-related bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan options.
• Paid time off and professional development opportunities.
• A dynamic and collaborative work environment in Nelspruit , focused on data integrity.

#J-18808-Ljbffr