Danish fluent Clinical Trial Start-Up Full Time Permanent

Clinical Trial Start Up Associate (Danish fluent)

Responsibilities:

• Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents,  serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams,  negotiate and obtain fully-executed contract,  track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• Identify, communicate, and resolve issues
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
• Leverage previous site / review board engagements to efficiently drive new work
• Populate internal systems to ensure accuracy of trial / site performance
• Understand and comply with procurements, legal and financial requirements and procedures
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Leverage trial prioritization
• Anticipate and monitor dynamically changing priorities

Qualification Requirements:

• Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
• Native Danish speaker and fluency in English is essential for this role.
• Understanding of the overall clinical development paradigm and the importance of efficient site initiation
• Applied knowledge of project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem solving skills
• Self-management and organizational skills
• Language capabilities in the followings (English, Danish)