Site Executive, GCTO

2024 December 27

This role is responsible for the performance and compliance of assigned protocols and sites in the region. Under the supervision of the CRA manager, the individual will ensure compliance with ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements. This role will act as the primary site contact and site manager during all phases of a clinical research study, taking overall responsibility for allocated sites and expanding the clinical research territory. Key Responsibilities: - Develops strong relationships with study sites and ensures continuity throughout all trial phases. - Manages clinical study site activities per ICH-GCP, Sponsor SOPs, local laws & regulations, and associated documentation. - Reviews and monitors required regulatory documentation for study initiation, maintenance, and closure. - Communicates with investigators and site staff regarding protocol conduct and site performance. - Identifies, assesses, and resolves site performance issues while escalating as needed. - Maintains accurate documentation in various systems (CTMS, eTMF). - Supports audit/inspection activities as necessary. This role focuses on managing clinical research sites to ensure compliance and performance according to set protocols and regulations. The position involves developing relationships with study sites, managing site activities, and collaborating with various internal and external stakeholders in the pharmaceutical research domain.

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