Study Start Up Associate

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

📋 Description

• Oversee the initiation process of clinical trials.

• Assist in site start-up and activation tasks.

• Prepare and submit necessary regulatory documentation.

• Gather and manage essential documents.

• Perform quality assessments of study documentation.

• Facilitate daily SSU activities while adhering to GCP/ICH guidelines and regulatory standards.

• Communicate and collaborate with study teams and other business stakeholders.

• Assist with site activation tasks, including submissions to MOH/IRB/EC and customizing ICF for country/site.

• Produce precise project status updates and financial data in tracking systems/tools.

• Recognize and escalate issues related to SSU deliverables.

• Carry out assigned SSU tasks.

• Aid in implementing 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 relevant clinical trial experience.

• Understanding of clinical trial execution.

• Experience with IVDR studies.

• Basic knowledge of drug development and ICH/GCP guidelines.

• Established project management capabilities.

• Familiarity with Veeva Vault TMF and Veeva CTMS.

• Exceptional interpersonal, written, and verbal communication skills.

• Strong administrative skills and computer proficiency.

• Fluent in English.

• Legal eligibility to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-based 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.