About the Role
Our client is seeking an experienced and highly organized Senior Clinical Data Manager to lead their data management activities for global clinical trials. This fully remote position allows you to manage critical data processes from your home office, ensuring the accuracy, completeness, and integrity of clinical trial data. You will be responsible for database design, data validation, and ensuring compliance with regulatory standards. This role is pivotal in supporting the timely completion of clinical studies and contributing to the development of life‑saving therapies, offering a significant impact on research outcomes from anywhere, including support for professionals based around Soweto .
Key Responsibilities
- Oversee the design, development, and validation of clinical databases using EDC systems.
- Develop and implement data management plans and standard operating procedures (SOPs).
- Lead data cleaning activities, including query generation and resolution, to ensure data accuracy and consistency.
- Manage data review meetings and ensure timely database lock according to study timelines.
- Ensure compliance with GCP, regulatory guidelines (e.g., FDA, EMA), and company policies.
- Mentor and guide junior data management staff and provide technical expertise.
Requirements
- Bachelor's degree in a relevant field such as Computer Science, Statistics, Life Sciences, or Nursing.
- Minimum of 7 years of experience in clinical data management, with at least 2 years in a senior or lead role.
- Extensive experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
- Strong understanding of clinical trial processes, database design, and data validation techniques.
- Proficiency in SQL and knowledge of CDISC data standards (SDTM, ADaM).
- Excellent communication, problem-solving, and project management skills for remote collaboration.
Benefits
- Competitive annual salary and comprehensive benefits package.
- Fully remote work flexibility with supportive technology and resources.
- Annual bonus and performance-based incentives.
- Opportunities for professional development and industry certifications.
- Work on impactful clinical trials that contribute to global health advancements, offering a rewarding career from anywhere in Gauteng .