Study Start Up Associate II

This is a fully remote position, open to applicants in Brazil, +2 more countries.

📋 Description

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

• Play a key role in site start-up and activation efforts, taking ownership of deliverables and collaborating effectively.

• Lead the preparation and submission of regulatory documents, which include clinical trial applications, submissions to ethics committees, and communications with regulatory agencies.

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

• Manage and uphold comprehensive and precise records of regulatory submissions, approvals, and correspondence.

• Offer guidance and assistance to study teams regarding regulatory requirements and best practices related to study start-up activities.

• Engage in process enhancement initiatives aimed at streamlining study start-up procedures and boosting efficiency.

⛳️ Requirements

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

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

• Strong knowledge of regulatory requirements and guidelines pertaining to clinical trials, including ICH-GCP and local regulations.

• Exceptional organizational and project management abilities, with the capacity to prioritize and handle multiple tasks concurrently.

• Outstanding communication and interpersonal skills, with the capability to work collaboratively 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 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 pathways.