Clinical Study Manager (On-site, Denmark)

Job summary

The Clinical Study Manager is responsible for overseeing the execution of clinical trials within the US and EU for a diagnostics company. This role ensures regulatory compliance and drives operational execution of clinical studies, achieving key milestones for new product development programs.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 5+ years of relevant experience, or a Master’s with 3+ years, or a Doctoral degree with 1+ year of experience.
• Comprehensive understanding of regulatory requirements such as ISO14155, ISO20916, and FDA GCP-ICH, as well as GDPR regulations.
• Minimum of 5 years of experience in study execution, data integrity, and project management for clinical studies within IVD/MD.

Responsibilities

• Oversee planning and execution of complex In-Vitro Diagnostic/Medical Device clinical studies from concept to close-out, ensuring adherence to protocols and regulatory requirements.
• Manage site selection, including contract negotiations, qualification, and budgeting.
• Conduct regular reviews of clinical study data and operational metrics to ensure data integrity and address performance or quality issues.
• Collaborate with stakeholders in the Clinical Development Team and harmonize the Quality Management System across multiple operating companies.

Skills

• Strong strategic and tactical planning skills.
• Excellent written and verbal communication skills.

Education

• Bachelor’s, Master’s, or Doctoral degree in a relevant field.

Tools

• Familiarity with Trial Master Files, Electronic Data Capture Systems, and Clinical Trial Management Systems (e.g., Veeva) is preferred.