Senior Global Clinical Trial Lead, End-to-End Operations

Gan & Lee Pharmaceuticals; Denmark; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Gan & Lee Pharmaceuticals in Denmark invites an experienced Senior Clinical Trial Manager to lead end-to-end sponsored trials, from protocol feasibility to submission, ensuring compliance with GCP, ICH, and company procedures.

You will oversee CROs, TMFs, budgets, recruitment plans, and study timelines, collaborating with cross-functional teams to deliver high-quality data and timely registrations.

Qualifications

• Bachelor of Science required, nursing/pharmacy or scientific field preferred.
• Nursing or pharmacy license preferred.
• Minimum 5+ years in industry with master’s or doctorate, or 8+ years without advanced degree.
• Experience managing multiple complex global clinical trials and strong drug development knowledge.

Responsibilities

• Ensure quality and compliance in all actions in line with procedures.
• Lead operational design and conduct of Gan & Lee sponsored trials from feasibility to submission.
• Coordinate protocol reviews and approvals with CROs and sites.
• Prepare study documents with CROs (ICDs, reports, training materials) and review eCRFs and data plans.
• Oversee TMF setup/maintenance to inspection readiness and study timelines.
• Manage budgets, invoices, and sponsor updates for senior management.
• Evaluate vendors/CROs and lead contracting with direct Gan & Lee contracts.
• Monitor CRO performance and sponsor oversight to ensure timelines and data quality.

Skills

Communication

MS Office

Study design

GCP & ICH

Multitasking

Adaptability

Attention to detail

Diabetes endocrinology

Regulatory submissions

Vendor management

Education

Bachelor of Science

Nursing/pharmacy license

Job description

Gan & Lee Pharmaceuticals in Denmark invites an experienced Senior Clinical Trial Manager to lead end-to-end sponsored trials, from protocol feasibility to submission, ensuring compliance with GCP, ICH, and company procedures.

You will oversee CROs, TMFs, budgets, recruitment plans, and study timelines, collaborating with cross-functional teams to deliver high-quality data and timely registrations.