Site Activation Specialist (Clinical Research, Denmark)

Job summary

The Site Activation Specialist is responsible for ensuring quality deliverables at the country level for clinical trials, adhering to project requirements and local regulations. This role involves monitoring project timelines, financial aspects, and compliance with Standard Operating Procedures (SOPs). The specialist supports continuous improvement in site start-up processes and acts as a liaison between investigational sites and functional leads.

Qualifications

• Experience in clinical trial site activation or related field.
• Knowledge of local regulatory requirements and clinical trial processes.
• Strong organizational and communication skills.

Responsibilities

• Ensure compliance with project timelines and track milestone progress in the SSU tracking system.
• Monitor financial aspects of projects and escalate discrepancies.
• Review and comply with SOPs and maintain training records.
• Support quality improvement in site start-up components, including submissions and document collection.
• Prepare and submit regulatory applications and ongoing submissions as required.
• Act as a liaison between investigational sites and project managers.
• Provide country-level intelligence on start-up and regulatory activities.

Skills

• Strong attention to detail and problem-solving abilities.
• Ability to work collaboratively in a team environment.
• Proficient in project management and tracking systems.

Education

• Relevant degree in life sciences or related field preferred.

Tools

• Familiarity with clinical trial management systems and regulatory submission platforms.