Remote Senior Clinical Trial Manager: Global Study Delivery

Blacksmith Agency Llc; Durban; Remote; ZAR 900.000 - 1.500.000; Vollzeit

Benefits dieser Stelle

Health insurance

Annual leave

Retirement planning

LifeWorks EAP

Zusammenfassung

ICON Strategic Solutions is seeking a Senior Clinical Trial Manager to lead country-level delivery, ensuring studies adhere to protocol, ICH GCP, regulatory, budget and timeline requirements. You will provide leadership to local study teams and drive execution from start-up through close-out.

You will oversee start-up activities, site activation, monitoring guidance to CRAs, budget management, and inspection readiness, collaborating with global study teams to support patient recruitment and

Qualifikationen

• Significant clinical research experience in CRA/Study Management or related Clinical Operations role.
• Strong knowledge of ICH GCP and country-specific regulatory requirements.
• Ability to lead cross-functional teams and manage multiple priorities.

Aufgaben

• Lead and coordinate country-level study delivery to meet timelines, budget and quality.
• Oversee country start-up activities including regulatory submissions and site activation.
• Ensure inspection readiness and TMF/eTMF documentation quality.
• Collaborate with global teams to support patient recruitment and study delivery.

Jobbeschreibung

ICON Strategic Solutions is seeking a Senior Clinical Trial Manager to lead country-level delivery, ensuring studies adhere to protocol, ICH GCP, regulatory, budget and timeline requirements. You will provide leadership to local study teams and drive execution from start-up through close-out.

You will oversee start-up activities, site activation, monitoring guidance to CRAs, budget management, and inspection readiness, collaborating with global study teams to support patient recruitment and