Remote Senior Clinical Trial Manager – Country Lead

Placements24; Durban; Remote; ZAR 900.000 - 1.200.000; Vollzeit

Benefits dieser Stelle

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Country-specific benefits

Zusammenfassung

ICON Strategic Solutions in Durban is seeking a Senior Clinical Trial Manager to lead country-level clinical study delivery, ensuring execution in line with protocol, ICH GCP, and regulatory standards. You will guide local study teams, manage start-up activities, and drive study delivery from start-up to close-out with inspection readiness.

You will collaborate with global study teams and vendors to support recruitment and successful delivery, while maintaining budgets and timelines.

Qualifikationen

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
• Significant clinical research experience in CRA/Senior CRA/Study Management or related Clinical Operations role.
• Strong knowledge of ICH GCP and country-specific regulatory requirements.
• Proven experience leading cross-functional teams and managing studies end-to-end.
• Excellent project management and stakeholder management skills; ability to handle multiple priorities.
• Willingness to travel approximately 25%.
• 3–5 years of project management experience; cardiovascular/respiratory experience desirable.

Aufgaben

• Oversee country-level delivery of clinical studies, ensuring adherence to protocol, ICH GCP, regulatory, budget, and timelines.
• Lead Local Study Teams (CRAs and support staff) to meet timelines, budget, and quality targets.
• Manage country start-up activities: feasibility, site selection/activation, regulatory/ethics submissions.
• Monitor study progress, identify risks, implement mitigations, and resolve operational issues.
• Oversee site monitoring activities and guide CRAs on protocol compliance and local regulations.
• Manage study budgets, investigator contracts, site payments and vendor activities.
• Maintain inspection readiness through TMF/eTMF, audits, and regulatory inspections.
• Collaborate with global teams, investigators, and vendors to support patient recruitment and study delivery.

Kenntnisse

ICH GCP knowledge

Project management

Cross-functional leadership

Travel readiness

Regulatory knowledge

Ausbildung

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field

Jobbeschreibung

ICON Strategic Solutions in Durban is seeking a Senior Clinical Trial Manager to lead country-level clinical study delivery, ensuring execution in line with protocol, ICH GCP, and regulatory standards. You will guide local study teams, manage start-up activities, and drive study delivery from start-up to close-out with inspection readiness.

You will collaborate with global study teams and vendors to support recruitment and successful delivery, while maintaining budgets and timelines.