About the Role
The Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM) is responsible for the overall operational management and execution of clinical trials and epidemiology studies. This role involves planning protocols, managing timelines, supervising site monitoring, managing study budgets, risk mitigation, and directing multi-disciplinary study teams to ensure compliance with global regulatory standards.
Key Responsibilities
- Operational Planning & Timeline Management: Develop the Protocol Management Plan (PMP) and coordinate across all functional departments. Establish and drive adherence to study timelines, proactively escalating issues as needed.
- Study Oversight & Trial Execution: Evaluate, set up, train, and monitor investigational sites. Actively manage study risks and formulate robust mitigation strategies.
- Budget & Vendor Management: Assist in defining which activities are outsourced, participate in vendor selection (CROs, labs), and lead the development and adherence of study budgets.
- Documentation & Protocol Support: Coordinate and draft study protocols, Informed Consent Documents, Study Operations Manuals, monitoring plans, and monitoring tracking forms.
- Site Monitoring Oversight: Review and approve site monitoring visit reports. Conduct monitoring oversight visits to verify clinical data accuracy and resolve discrepancies.
- Team Leadership & Mentorship: Lead trial meetings, coordinate with collaborators, and mentor/train Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs), and Clinical Operations Specialists (COS).
- Regulatory Compliance: Adhere to ICH GCP, FDA CFR, Declaration of Helsinki, and other relevant local and international regulatory guidelines.
Requirements and Experience
- Education: A Bachelor's degree in a scientific or related field is required (an advanced degree is highly preferred).
- Experience Requirements (CTM): Minimum of 5 years of experience in trial operations, with at least 2 years in trial management.
- Experience Requirements (Sr. CTM): Minimum of 7 years of relevant experience in clinical trial operations, with at least 4 years in trial management or equivalent experience within a study sponsor or CRO.
- Expert Knowledge: Deep understanding of Good Documentation Practices, ICH GCP, and FDA CFR is required. Familiarity with HIV, TB, vaccine trials, or emerging infectious diseases in Sub-Saharan Africa is highly desirable.
- Systems Proficiency: Experience working with electronic document management systems (e.g., Veeva) and electronic data capture (EDC) systems.
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