Lead Clinical Data Manager - Pharmaceutical Trials

Our client, a globally recognized pharmaceutical leader, is actively seeking an experienced and dynamic Lead Clinical Data Manager to spearhead data management operations for their critical clinical trials. This pivotal role, based remotely but overseen for the Cape Town, Western Cape region, will ensure the integrity, accuracy, and completeness of clinical trial data from study startup through database lock. You will lead a team of data managers, establish and enforce data management standards, and collaborate closely with cross-functional teams, including clinical operations, biostatistics, and IT.

This is an exceptional opportunity to contribute to the development of life-saving medications while enjoying the flexibility of a fully remote position. Your expertise will be vital in maintaining compliance and driving efficient data operations.

• Lead and mentor a team of clinical data managers, providing guidance on study conduct and data management best practices.
• Oversee the design, development, and validation of clinical databases using EDC systems.
• Develop and maintain comprehensive Data Management Plans (DMPs) for assigned clinical studies.
• Define data collection standards, Case Report Form (CRF) design, and edit check specifications.
• Manage data cleaning activities, including query generation, resolution, and trend analysis.
• Ensure adherence to Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, EMA), and company SOPs.
• Liaise with external vendors, including CROs and technology providers, to ensure seamless data flow and integration.
• Participate in clinical trial team meetings, providing updates on data management status and risks.
• Contribute to the continuous improvement of data management processes and systems.
• Ensure timely database lock for assigned studies.

• Bachelor's degree in a relevant scientific or technical field (e.g., Computer Science, Statistics, Life Sciences). A Master's degree is a plus.
• A minimum of 7 years of progressive experience in clinical data management within the pharmaceutical or CRO industry.
• At least 3 years of experience in a lead or supervisory role managing data management teams.
• In-depth knowledge of Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault EDC).
• Strong understanding of clinical trial phases, study design, and regulatory requirements (GCP, ICH guidelines).
• Proficiency in database design, data validation strategies, and data quality control techniques.
• Excellent leadership, communication, and interpersonal skills.
• Proven ability to manage multiple projects simultaneously in a remote, fast-paced environment.
• Strong problem-solving skills and attention to detail.

• This remote position offers a highly competitive salary, comprehensive health and wellness benefits, performance-based incentives, generous annual leave, and a retirement savings plan.
• We provide opportunities for professional development, including access to training and conferences.
• As part of our commitment to work-life balance, you will enjoy the flexibility of working from home, supporting our operations in the Cape Town, Western Cape region and beyond.