The role involves preparing, reviewing, and coordinating local regulatory submissions aligned with global submission strategies while serving as a primary contact for investigators and regulatory authorities
Job Summary
The role involves preparing, reviewing, and coordinating local regulatory submissions aligned with global submission strategies while serving as a primary contact for investigators and regulatory authorities.
Responsibilities include conducting site feasibility assessments, managing site start-up activities, negotiating contracts, and ensuring compliance with protocols and regulatory requirements.
The position supports effective communication among sites, clients, and project teams, participates in meetings and audits, and contributes to process improvements and project work.
Matching Summary
The role involves preparing, reviewing, and coordinating local regulatory submissions aligned with global submission strategies while serving as a primary contact for investigators and regulatory authorities.
Skills & Requirements
Must-have
Local regulatory submissions coordination
Site feasibility and selection assessments
Clinical trial site initiation and monitoring
Informed Consent Form development and negotiation
Contract negotiation within client parameters
Regulatory compliance and documentation management