Global Clinical Trials Lead - End-to-End Study Execution

Gan & Lee Pharmaceuticals; Denmark; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Gan & Lee Pharmaceuticals is seeking a Senior Clinical Trial Manager to lead end-to-end sponsored trials. The role can be based in Denmark or the US, reporting to the Head of Clinical Operations.

You will collaborate with the study team to drive operational excellence, ensure regulatory compliance, and oversee TMFs and budgets. The position requires extensive trial management experience, strong communication, and familiarity with global regulatory requirements.

Qualifications

• Bachelor of Science required, nursing/pharmacy or scientific field preferred.
• License in nursing or pharmacy is preferred.

Responsibilities

• Lead and oversee Gan & Lee sponsored trials from feasibility to submission.
• Ensure compliance with GCP, ICH, and applicable regulations.
• Collaborate with cross-functional teams and CROs for study execution.
• Manage budgets, timelines, and vendor contracts.
• Maintain inspection-ready TMFs and study documentation.
• Monitor recruitment plans and data quality across studies.

Skills

Communication skills

MS Office

Study design

GCP & ICH knowledge

Prioritization

Adaptability

Attention to detail

Diabetes/Endocrinology knowledge

Regulatory submissions experience

Vendor management

Education

Bachelor's degree in a scientific field

Nursing/Pharmacy license preferred

Job description

Gan & Lee Pharmaceuticals is seeking a Senior Clinical Trial Manager to lead end-to-end sponsored trials. The role can be based in Denmark or the US, reporting to the Head of Clinical Operations.

You will collaborate with the study team to drive operational excellence, ensure regulatory compliance, and oversee TMFs and budgets. The position requires extensive trial management experience, strong communication, and familiarity with global regulatory requirements.