Study Start Up Associate II

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

📋 Description

• Oversee the initiation of clinical trials.

• Assist in site start-up and activation processes.

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

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

• Maintain comprehensive records of regulatory submissions, approvals, and related correspondence.

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

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

⛳️ Requirements

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

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

• In-depth knowledge of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations.

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

• Strong 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

• Attractive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career paths.