Study Start Up Associate II

This is a fully remote position, open to applicants in Spain, +3 more countries.

📋 Description

• Oversee the initiation of clinical trials

• Assist in site start-up and activation processes

• Prepare and submit regulatory documents, such as clinical trial applications and ethics committee submissions

• Collaborate with both internal and external stakeholders to secure necessary approvals and authorizations for study initiation

• Maintain records of regulatory submissions, approvals, and communications

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

• Engage in process improvement initiatives aimed at optimizing study start-up procedures and boosting efficiency

⛳️ 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

• Proficiency in English and your local language, along with German, French, Romanian, or Dutch

• Exceptional organizational and project management abilities, capable of prioritizing and managing multiple tasks simultaneously

• Outstanding communication and interpersonal skills, with the capacity to collaborate effectively within cross-functional teams

• Willingness to travel as necessary (approximately 5%)

• Legal authorization to work in the country where the position is located

🏝️ Benefits

• Competitive base salary along with performance-related incentives

• Health and wellness programs, including medical, dental, and vision coverage when 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