Global Clinical Operations Director: Trials & CRO

Henlius; Singapore; Vor Ort; SGD 180.000 - 240.000; Vollzeit

Zusammenfassung

Henlius is seeking an experienced Senior Clinical Operations Lead in Singapore to oversee study planning, monitoring, and vendor management across Phase I–III oncology trials. You will coordinate cross-functional teams, ensure regulatory compliance, and manage budgets and timelines. Strong leadership and global trial experience are required.

The role emphasizes CRO oversight, site management, and collaboration with SMT to drive study success and high-quality deliverables.

Qualifikationen

• Familiar with GCP, NMPA regulations, ICH-GCP regulations, and other drugs' clinical trial quality management specifications.
• Experience in clinical project supplier management, project management, financial management, and quality control.
• Experience in managing global studies from Phase I to III.
• Demonstrate proficiency in ICH rules and global regulatory guidelines.

Aufgaben

• Ensure appropriate monitoring oversight plans reflect adherence to regulations and SOPs.
• Lead study planning to ensure timeline, budget, and resources.
• Oversee CROs and vendors in collaboration with SMT.
• Lead the clinical core team in executing study tasks per the plan.
• Monitor KPIs and study metrics; provide status reports to management.
• Identify risks and implement mitigation plans with stakeholders.
• Serve as sponsor contact for site issues and oversee site activations and closeouts.
• Conduct monitor assessment visits and support site inspections and audits.
• Provide professional guidance to team members.

Kenntnisse

GCP familiarity

ICH-GCP familiarity

NMPA regulatory knowledge

Global trial management

Clinical project management

CRO/vendor management

Budget & financial oversight

Oncology drug development

Ausbildung

Bachelor’s degree or higher in clinical field

Jobbeschreibung

Henlius is seeking an experienced Senior Clinical Operations Lead in Singapore to oversee study planning, monitoring, and vendor management across Phase I–III oncology trials. You will coordinate cross-functional teams, ensure regulatory compliance, and manage budgets and timelines. Strong leadership and global trial experience are required.

The role emphasizes CRO oversight, site management, and collaboration with SMT to drive study success and high-quality deliverables.