Global Clinical Trial Leader - End-to-End

Gan & Lee Pharmaceuticals; New York (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Gan & Lee Pharmaceuticals is seeking a Senior Clinical Trial Manager to lead development, planning, conduct, and submission of sponsored trials. You will work with the Study Team to provide operational leadership across one or more studies, reporting to the Head of Clinical Operations, with work in US or Denmark.

You will ensure compliance with GCP/ICH, manage budgets and CROs, coordinate TMFs, and drive study timelines, risk mitigation, and regulatory submissions while maintaining patient

Qualifications

• Bachelor of Science degree, preferably in Nursing, Pharmacy, or scientific field.
• Nursing or pharmacy license preferred.

Responsibilities

• Lead the operational design and conduct of Gan & Lee sponsored clinical trials from protocol feasibility through database lock, study report generation, and submission activities.
• Coordinate protocol reviews and approvals and manage TMFs with CROs to ensure inspection readiness.
• Oversee development of budgets, invoices, and vendor management, and ensuring compliance with GCP and regulatory requirements.

Skills

Communication skills

MS Office proficiency

Study design

GCP & ICH

Multi-tasking

Attention to detail

Therapeutic area knowledge

Regulatory submissions

Vendor management

Education

Bachelor of Science degree

Nursing/pharmacy license

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Microsoft PowerPoint

Job description

Gan & Lee Pharmaceuticals is seeking a Senior Clinical Trial Manager to lead development, planning, conduct, and submission of sponsored trials. You will work with the Study Team to provide operational leadership across one or more studies, reporting to the Head of Clinical Operations, with work in US or Denmark.

You will ensure compliance with GCP/ICH, manage budgets and CROs, coordinate TMFs, and drive study timelines, risk mitigation, and regulatory submissions while maintaining patient