Study Start-Up Associate

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

📋 Description

• Oversee the commencement of clinical trials and play a key role in advancing groundbreaking treatments and therapies.

• Engage in site start-up and activation tasks, taking ownership of deliverables and collaborating with various stakeholders.

• Prepare and file regulatory documents, such as clinical trial applications and submissions to ethics committees.

• Coordinate with both internal and external stakeholders to secure approvals and authorizations for the initiation of studies.

• Manage and uphold precise records of regulatory submissions, approvals, and correspondence.

• Offer guidance and assistance to study teams regarding regulatory requirements and best practices for study start-up.

• Participate in initiatives aimed at process improvement to enhance the efficiency of study start-up procedures.

⛳️ Requirements

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

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

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

• Exceptional organizational and project management abilities, with the capacity to prioritize and handle multiple tasks simultaneously.

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

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

• Legal authorization to work in Spain.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs that include 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.