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Placements24 is seeking an experienced Clinical Trial Manager to oversee multi-center trials within a hybrid work model based in Kimberley, Northern Cape. You will lead trial execution from initiation to close-out, ensuring compliance with ICH-GCP, budgets, timelines, and TMF readiness.
The ideal candidate has a life sciences degree, 5+ years in CTM, strong leadership and communication skills, and hands-on experience with CTMS, EDC, and eTMF.
Our client, a growing contract research organization (CRO) dedicated to excellence in clinical research, is seeking an experienced and highly organized Clinical Trial Manager (CTM) to oversee complex, multi-center clinical trials. This role, based out of our Kimberley, Northern Cape office, requires a proactive leader who can manage all aspects of trial execution from initiation to closure. You will be responsible for ensuring trials are conducted in compliance with protocols, regulations, and company standards, while managing budgets, timelines, and resources effectively. This hybrid position combines essential on-site coordination with remote oversight and administrative tasks, offering a dynamic work environment. The ideal candidate possesses strong leadership abilities, a comprehensive understanding of clinical trial operations, and excellent communication and interpersonal skills. We are seeking an individual who can motivate study teams and ensure the successful delivery of high-quality clinical trial data.
Manage the planning, execution, and completion of assigned clinical trials in accordance with ICH-GCP, SOPs, and regulatory requirements. Oversee and coordinate activities of Clinical Research Associates (CRAs) and other study personnel, providing guidance and support. Develop and manage study budgets, timelines, and resource allocation to ensure efficient trial conduct. Ensure timely site selection, initiation, monitoring, and close-out activities. Oversee data management activities, ensuring data quality, integrity, and query resolution. Liaise with internal departments (e.g., Regulatory Affairs, Safety, Data Management) and external stakeholders (e.g., investigators, ethics committees, vendors). Develop and maintain trial master files (TMF) and other essential study documentation. Monitor trial progress, identify risks and issues, and implement mitigation strategies to keep trials on track. Ensure compliance with all applicable regulatory requirements and ethical standards. Prepare study progress reports and contribute to clinical study reports (CSRs).
Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree or equivalent experience is preferred. Minimum of 5 years of experience in clinical trial management, with demonstrated success in managing multiple complex trials. Strong understanding of ICH-GCP guidelines and regulatory requirements across different regions. Proven experience in managing study budgets, timelines, and cross-functional teams. Excellent leadership, communication, negotiation, and interpersonal skills. Proficiency in clinical trial management software (CTMS), EDC systems, and eTMF. Ability to work independently and collaboratively, manage multiple projects, and adapt to a hybrid work model. Strong problem-solving and decision-making abilities. Attention to detail and a commitment to data quality and patient safety. Relevant certifications (e.g., ACRP, SoCRA) are a plus.
Our client offers a competitive salary package, including performance-based incentives and a comprehensive benefits program covering health insurance, life cover, and retirement contributions. This hybrid role provides a flexible work arrangement, balancing office-based collaboration with remote work flexibility. You will have the opportunity to manage impactful clinical trials and grow your career within a reputable CRO. We are committed to your professional development, offering training opportunities, conference attendance, and clear career progression paths. Additional benefits include travel allowances and access to cutting-edge clinical research technologies.