Clinical Operations Manager - Regulatory
iqvia
Job description
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 oversees budget management, regulatory submissions, site readiness, and coordination with internal and external stakeholders.
Key responsibilities
- Own country and site budgets, develop and negotiate Clinical Trial Research Agreements, and track related payments.
- Execute and oversee clinical trial submissions and approvals, including development of local language informed consents and interactions with IRB/IEC and regulatory authorities.
- Manage country deliverables, timelines, and results to meet commitments, ensuring quality and compliance across protocols.
- Coordinate with Project Managers, CTAs, CRAs, and headquarters to align timelines, budgets, and local milestones.
- Oversee local processes such as supplies management, import/export requirements, archiving, and insurance processes.
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Published 7 hours ago
Expires 1 month from now
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iqvia