Study Start Up Associate

This is a fully remote position, open to applicants in Denmark.

📋 Description

• Oversee the initiation of clinical trials, ensuring adherence to regulatory standards.

• Play a key role in site start-up and activation tasks, taking ownership of deliverables and collaborating with team members.

• Prepare and submit necessary regulatory documents, including clinical trial applications and submissions to ethics committees.

• Coordinate and communicate with both internal and external stakeholders to secure required approvals.

• Manage and uphold detailed and accurate records of regulatory submissions and related correspondence.

• Offer guidance and support to study teams concerning regulatory expectations.

• Engage in process enhancement initiatives aimed at optimizing study start-up procedures.

⛳️ Requirements

• A Bachelor's degree in life sciences or a related discipline.

• At least 2 years of experience in clinical research or regulatory affairs, particularly in study start-up activities.

• Strong comprehension of regulatory standards and guidelines for clinical trials, including ICH-GCP and local regulations.

• Exceptional organizational and project management abilities, with a knack for prioritizing and handling multiple tasks at once.

• Outstanding communication and interpersonal skills, capable of effective collaboration with cross-functional teams.

• Willingness to travel as necessary (approximately 5%).

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.