Site Activation Specialist (Clinical Research, Denmark)

Job summary

The role involves overseeing site activation processes and ensuring compliance with project requirements and local regulations in the clinical research sector. The specialist will work closely with various stakeholders to facilitate timely submissions and approvals while maintaining quality deliverables.

Qualifications

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

Responsibilities

• Manage quality deliverables at the country level, ensuring compliance with timelines and tracking progress in the SSU system.
• Monitor financial aspects of projects and report discrepancies.
• Review and adhere to Standard Operating Procedures (SOPs) and maintain training records.
• Support continuous improvement in Site Start-Up (SSU) components, including submissions and document collection.
• Ensure all relevant documents are submitted to the Trial Master File (TMF).
• Act as a liaison between investigational sites and functional leads, overseeing the site activation process.
• Provide country-level intelligence on start-up and clinical trial regulations.
• Assist in local investigator contract and budget negotiations.

Skills

• Proficient in project management and regulatory compliance.
• Strong analytical and problem-solving abilities.
• Excellent interpersonal skills for stakeholder engagement.

Education

• Relevant degree in life sciences, healthcare, or related field preferred.

Tools

• Familiarity with SSU tracking systems and regulatory submission platforms.