Study Start Up Associate II

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

📋 Description

• Oversee the commencement of clinical trials

• Assist with site start-up and activation processes

• Prepare and submit regulatory documentation

• Gather and manage essential documentation

• Perform quality reviews of study materials

• Aid in daily SSU activities in accordance with GCP/ICH standards and regulatory requirements

• Communicate and coordinate with key stakeholders and study teams

• Assist with site activation tasks, MOH/IRB/EC submissions, and ICF customization for countries/sites

• Generate and deliver precise project status and financial data in tracking systems/tools

• Identify and escalate issues related to SSU outcomes

• Implement assigned SSU tasks

• Support the establishment of standards for the global SSU team

⛳️ Requirements

• BS/BA degree or an Associate's degree with a minimum of 3 years of experience in the healthcare sector or direct clinical trial experience

• Understanding of clinical trial execution

• Experience with IVDR studies

• General knowledge of drug development and ICH/GCP guidelines

• Demonstrated project management capabilities

• Familiarity with Veeva Vault TMF and Veeva CTMS

• Exceptional interpersonal, written, and verbal communication skills

• Strong administrative skills and proficient computer abilities

• Proficient in English

• Legal eligibility 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 schemes

• Life insurance and disability coverage

• Employee assistance programs and wellness resources

• Learning and development opportunities through structured training and career pathways