Clinical Operations Manager - Regulatory
Core
Ensures performance and compliance for assigned clinical protocols in a specific country, managing budgets, regulatory submissions, and site readiness.
Role type
Senior IC clinical operations manager (regulatory)
Builds
Country-specific clinical trial deliverables and financial contracts
Domain
Life sciences / Clinical research
Deliverable
client delivery
Required skills
Budget management, Clinical Trial Research Agreement (CTRA) negotiation, Regulatory submission execution, Local language material development, Vendor management, Supply chain logistics, Financial compliance, SOP development
Preferred skills
Process improvement, Mentoring, Stakeholder influence
Technologies
Clinical and finance systems
Responsibilities
Own country and site budgets and negotiate CTAs; Execute and oversee clinical trial country submissions and approvals; Develop local language materials and interact with IRB/IEC and Regulatory Authorities; Manage country deliverables, timelines, and results; Oversee clinical and ancillary supplies management and archiving; Provide support and oversight to local vendors; Act as a Subject Matter Expert for process improvements.
