Regulatory and Start Up Specialist (Nordics)

Job summary

This role involves executing Site Activation (SA) activities at a country level, ensuring compliance with local and international regulations, standard operating procedures (SOPs), and project requirements. The position requires fluency in Swedish, Finnish, and Danish, along with experience in EC/RA submissions and a strong grasp of local regulatory requirements.

Qualifications

• Bachelor’s Degree in life sciences or a related field.
• Minimum of 3 years of clinical research or relevant experience, or equivalent combination of education and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Familiarity with GCP/ICH and applicable regulatory guidelines.
• Understanding of the regulated clinical trial environment and drug development process.

Responsibilities

• Act as the Single Point of Contact (SPOC) for investigative sites and project teams.
• Ensure compliance with SOPs, quality of deliverables, and adherence to project timelines.
• Conduct start-up and site activation activities in line with regulations and SOPs.
• Prepare and review site regulatory documents for accuracy and completeness.
• Maintain internal systems and databases with project-specific information.
• Monitor site performance metrics and provide feedback to management.
• Establish project planning and timelines, implementing contingency plans as necessary.
• Ensure completion of regulatory and contractual documents for sites.
• Perform quality control of documents submitted by sites.

Skills

• Strong understanding of local regulatory requirements and clinical trial processes.
• Excellent communication and organizational skills.

Education

• Bachelor’s Degree in life sciences or a related field.

Tools

• Familiarity with clinical research systems and tracking tools.