Clinical Operations Manager – Regulatory

About the role

This position is responsible for the performance and compliance of assigned clinical trial protocols in Uganda, ensuring adherence to ICH/GCP, local regulations, sponsor policies, and quality standards. The role reports to the line manager and oversees budget, finance, and regulatory submissions.

Key responsibilities

• Own country and site budgets, develop and negotiate Clinical Trial Research Agreements (CTRA), and track related payments.
• Execute and oversee clinical trial submissions and approvals, including interaction with IRB/IEC and regulatory authorities.
• Develop local language materials such as informed consents and manage translation processes.
• Coordinate with project managers, CRA, and CTA to meet country deliverables, timelines, and milestones.
• Manage clinical supplies, import/export requirements, archiving, and insurance processes.
• Maintain compliance with local regulatory and financial requirements and update clinical and finance systems.

Required profile

• Experience managing clinical trial budgets, contracts, and regulatory submissions in a country setting.
• Ability to work with internal teams and external partners, including investigators, vendors, IRBs/IECs, and regulatory authorities.
• Strong understanding of ICH/GCP guidelines and local regulatory frameworks.

Required skills

• Knowledge of ICH/GCP and country-specific regulatory requirements.
• Budget and financial management for clinical trials.
• Contract negotiation and management (CTRA).