Clinical Operations Manager
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About the Role
Our client, a rapidly growing Contract Research Organization (CRO), is seeking an experienced Clinical Operations Manager to lead their team in Kimberley, Northern Cape, ZA . This crucial role will oversee the planning, execution, and completion of clinical trials, ensuring adherence to timelines, budgets, and quality standards. You will manage a team of clinical research professionals, provide strategic direction, and foster a collaborative and high-performance culture. The ideal candidate will possess strong leadership skills, a deep understanding of clinical trial processes, and a commitment to operational excellence. This is a significant opportunity to shape the future of clinical research within a dynamic and expanding organization based in the heart of the Northern Cape .
Key Responsibilities
- Lead and manage the clinical operations department, including project planning, resource allocation, and team development.
- Oversee the execution of multiple clinical trials from initiation through close-out.
- Ensure compliance with all relevant regulatory requirements (GCP, ICH) and company SOPs.
- Develop and manage clinical trial budgets and timelines, ensuring efficient resource utilization.
- Collaborate with internal departments (e.g., Data Management, Regulatory Affairs, Biostatistics) to ensure seamless trial execution.
- Build and maintain strong relationships with investigative sites, vendors, and study sponsors.
- Implement process improvements to enhance the efficiency and quality of clinical trial operations.
- Monitor trial progress, identify risks, and develop mitigation strategies.
- Recruit, train, and mentor clinical research staff.
- Contribute to business development activities and proposal development.
Requirements
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
- Minimum of 7-10 years of experience in clinical operations within the pharmaceutical or CRO industry, with at least 3 years in a management role.
- Extensive experience in managing all phases of clinical trials (Phase I-IV).
- Proven track record of successfully managing clinical trial budgets and timelines.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Excellent leadership, team management, and communication skills.
- Proficiency in Clinical Trial Management Systems (CTMS) and EDC systems.
- Strong analytical and problem-solving abilities.
- Ability to work effectively in a fast-paced, demanding environment.
- Experience in vendor management.
Benefits
- Our client offers a highly competitive salary package, including performance-based bonuses, comprehensive medical aid, a retirement savings plan, and life insurance.
- We provide opportunities for professional development, including leadership training, conference attendance, and support for further education.
- This role is based in our Kimberley office, providing a stable and professional work environment.
- We believe in fostering a healthy work-life balance and offer generous annual leave.
- Join a growing organization that values its employees and is committed to delivering high-quality clinical research services.
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