Study Start Up Specialist

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

📋 Description

• Act as the Single Point of Contact (SPOC) for assigned studies, serving investigative sites, Site Activation Managers, Project Management teams, and other departments.

• Ensure compliance with Standard Operating Procedures (SOPs), Work Instructions, quality of deliverables, and adherence to project timelines.

• Conduct start-up and site activation activities in accordance with regulations, SOPs, and work instructions.

• Distribute finalized documents to sites and internal project team members.

• Prepare site regulatory documents, ensuring they are complete and accurate.

• Complete and maintain internal systems, databases, and tracking tools with project-specific information.

• Analyze site performance metrics and provide constructive feedback to management.

• Review, establish, and agree upon project planning and timelines.

• Ensure monitoring measures are implemented and contingency plans are executed when necessary.

• Update team members on the completion of regulatory and contractual documents for individual sites.

• Review, monitor, and follow up on regulatory, ethics, Informed Consent Form (ICF), and Investigational Product (IP) release documents.

• Offer local expertise to Site Activation Managers and project teams during the planning of project timelines.

• Conduct quality control of documents submitted by sites.

• Maintain necessary activities as required.

• Engage directly with sponsors on specific initiatives.

⛳️ Requirements

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

• A minimum of 3 years of clinical research experience.

• Comprehensive understanding of clinical systems, procedures, and corporate standards.

• Proficient in applying Good Clinical Practice (GCP)/International Council for Harmonisation (ICH) and relevant regulatory guidelines.

• Familiarity with pertinent regulatory requirements, including local regulations, SOPs, and the company’s Corporate Standards.

• Insight into the regulated clinical trial environment and knowledge of the drug development process.

• Extensive knowledge of the UK clinical trial landscape and submission processes.

🏝️ Benefits

• Opportunity for remote work.

• Full-time employment.