Study Start Up Associate II, German-Speaker

This is a fully remote position, open to applicants in Poland, +5 more countries.

📋 Description

• Facilitate the initiation of clinical trials while ensuring adherence to regulatory standards.

• Execute site start-up and activation tasks to a high level of quality.

• 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.

• Keep accurate and current records of all regulatory submissions and approvals.

• Assist study teams in the development of protocols, informed consent forms, and investigator brochures.

• Engage in study start-up meetings to provide insight on regulatory requirements and timelines.

⛳️ Requirements

• Professional fluency in English and German, along with proficiency in French or Romanian.

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

• Prior experience in clinical research or regulatory affairs is preferred but not mandatory.

• Strong attention to detail coupled with excellent organizational skills.

• Outstanding communication and interpersonal abilities, with a knack for effective collaboration across cross-functional teams.

• Capacity to work independently and manage multiple tasks concurrently in a dynamic environment.

• 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 insurance and disability coverage.

• Employee assistance programs and wellness resources.

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