Study Start Up Associate II

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

📋 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 fostering collaboration.

• Direct the preparation and submission of regulatory documents, such as clinical trial applications, ethics committee submissions, and communications with regulatory agencies.

• Coordinate and engage with both internal and external stakeholders to secure necessary approvals and authorizations for commencing studies.

• Manage and keep thorough and precise records of regulatory submissions, approvals, and correspondences.

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

• Take part in initiatives aimed at improving processes to streamline study start-up activities and boost efficiency.

⛳️ Requirements

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

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

• Strong comprehension 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 manage multiple tasks effectively.

• Outstanding communication and interpersonal skills, with the ability to collaborate successfully with cross-functional teams.

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

• Legal authorization to work in Romania.

🏝️ 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.