Senior Study Start-up Lead LATAM - Remote

Emmes; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading clinical research organization is looking for a Study Start-up Associate Senior to spearhead the preparation and submission of regulatory packages for clinical trials. The role requires overseeing global activities and ensuring compliance with regulatory requirements. Candidates should possess a bachelor's degree, have over 6 years of experience in study start-up, and demonstrate strong analytical and communication skills. This role offers the opportunity to impact patient lives and contribute to innovative clinical research initiatives.

Qualifications

• 6+ years of experience in study start-up and/or regulatory affairs for clinical research.
• At least 2 of the 6 years in more than 2 countries.
• Strong knowledge of clinical research processes and local regulatory regulations.

Responsibilities

• Prepare, adapt, and submit regulatory and ethics packages to ensure compliance.
• Coordinate timelines and country-specific strategies for submissions.
• Track and maintain essential regulatory documents for study activation.

Skills

Project management

Communication

Regulatory knowledge

Analytical skills

Organizational skills

Education

Bachelor degree preferably in life sciences

Job description

A leading clinical research organization is looking for a Study Start-up Associate Senior to spearhead the preparation and submission of regulatory packages for clinical trials. The role requires overseeing global activities and ensuring compliance with regulatory requirements. Candidates should possess a bachelor's degree, have over 6 years of experience in study start-up, and demonstrate strong analytical and communication skills. This role offers the opportunity to impact patient lives and contribute to innovative clinical research initiatives.