Study Start Up Associate II

This is a fully remote position, open to applicants in Poland, +6 more countries.

📋 Description

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

• Play a key role in site start-up and activation tasks, taking charge of project deliverables.

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

• Engage in communication with regulatory authorities.

• Collaborate with both internal and external stakeholders to secure approvals and authorizations for starting studies.

• Manage and keep records of regulatory submissions, approvals, and related correspondence.

• Offer guidance and support to study teams regarding regulatory requirements and best practices for study initiation.

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

• Work in collaboration with cross-functional teams.

⛳️ Requirements

• A 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, as well as German, French, Romanian, or Dutch.

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

• Outstanding communication and interpersonal skills, enabling effective collaboration with 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 where 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 progression pathways.