Study Start Up Associate II

This is a fully remote position, open to applicants in Brazil, +1 more country.

📋 Description

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

• Assist in site start-up and activation processes.

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

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

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

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

• Engage in process enhancement initiatives aimed at optimizing study start-up procedures to improve efficiency.

⛳️ Requirements

• A bachelor's degree in life sciences or a relevant field.

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

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

• Exceptional organizational and project management skills, with the capacity to prioritize and handle multiple tasks at once.

• Strong communication and interpersonal abilities, enabling effective collaboration with cross-functional teams.

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

• Legal authorization to work in the country where the position is based.

🏝️ 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 pathways.