Senior Clinical Trial Manager (Clinical Operations)

Location: United States or Denmark

Company

Gan & Lee Pharmaceuticals develops pharmaceutical products and sponsors clinical research programs.

What you will do

• Lead clinical studies from protocol feasibility and operational design through database lock, study reports, and submission activities.
• Coordinate protocol reviews, approvals, study-specific documents, recruitment materials, and clinical trial registry postings.
• Oversee CROs, laboratories, investigators, and other external service providers, serving as the primary contact for assigned CROs.
• Manage study timelines, critical path activities, recruitment and retention, risks, budgets, contracts, invoices, and payment schedules.
• Maintain inspection-ready Trial Master Files and ensure compliance with protocols, contracts, GCP, ICH, and applicable regulations.
• Coordinate clinical supplies, labeling, shipments, drug accountability, and drug return or destruction processes.

Requirements

• Must be based in the United States or Denmark.
• Bachelor of Science degree or equivalent, preferably in nursing, pharmacy, or a scientific field.
• At least 5 years of relevant industry experience with a master's or doctorate, or at least 8 years without an advanced degree.
• Experience managing multiple complex global clinical trials and strong knowledge of drug development principles.
• Proficiency in GCP and ICH regulations, Microsoft Word, Excel, Project, and PowerPoint.
• Strong communication, organization, prioritization, attention to detail, and cross-functional collaboration skills.

Nice to have

• Nursing or pharmacy license relevant to the degree.
• Knowledge of diabetes, endocrinology, or weight management therapeutic areas.
• Experience supporting regulatory submissions and managing vendors.

Culture & Benefits

• Cross-functional collaboration with internal and external study teams.
• Opportunities to lead departmental initiatives and process improvements.
• Responsibility for operational excellence, knowledge sharing, and continuous improvement.
• Mentoring opportunities for junior employees, interns, and consultants.