Regulatory and Start Up Specialist (Clinical Research)

Location: Copenhagen, Denmark

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Serve as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
• Perform country-level regulatory, start-up, and site activation activities in line with applicable regulations, SOPs, work instructions, and project requirements.
• Prepare, review, distribute, and quality-control regulatory, ethics, informed consent, investigator pack, and contractual documents.
• Track document approvals, execution, site progress, project timelines, deliverables, and information in internal systems and databases.
• Provide local regulatory expertise, review site performance metrics, and support contingency planning.
• Communicate with project teams, management, sites, and sponsors on regulatory and contractual activities.

Requirements

• Bachelor’s degree in life sciences or a related field and 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
• Fluency in Swedish, Finnish, and Danish.
• Knowledge of clinical systems, procedures, corporate standards, and the regulated clinical trial environment.
• Ability to apply GCP/ICH and applicable local and international regulatory guidelines.
• Understanding of the drug development process and local regulatory requirements.

Nice to have

• Experience with medical devices.
• Experience with contract negotiations.

Culture & Benefits

• Full-time employment within an FSP setting.
• Work involving international clinical research projects and cross-functional collaboration.
• Responsibilities aligned with documented SOPs, quality standards, and project timelines.