Site Activation Partner – Temporary

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

📋 Description

• Lead and oversee site activation initiatives and manage essential documentation to ensure timely initiation and start-up of studies.

• Collaborate with investigator sites to evaluate readiness, review site details, and fulfill Investigator Initiation Package prerequisites.

• Prepare, validate, and submit regulatory documents, including Investigator Initiation Packages, IRB approvals, and FDA 1572 or Attestation Forms.

• Handle investigator site registration and maintenance within client systems, registries, and clinical trial platforms.

• Work in tandem with study teams and supporting functions to meet site activation and operational goals.

• Assist with ethics committee and IRB submissions, communications, approvals, and ongoing maintenance tasks.

• Organize document translation efforts with approved vendors.

• Manage the collection, maintenance, filing, archiving, and contributions to the trial master file of essential documents.

• Maintain clinical trial systems and tracking tools to ensure site compliance, document status, and study performance.

• Aid in preparing for audits and inspections and assist with responses.

• Identify, resolve, and escalate site-related challenges while supporting corrective and preventive actions.

• Contribute to process enhancements, system expertise, knowledge sharing, and mentoring initiatives.

⛳️ Requirements

• A Bachelor's degree.

• At least 2 years of relevant experience in clinical site management with a focus on study site activation.

• Knowledge of clinical trial methodologies, ICH/GCP, FDA regulations, and relevant global and local regulatory requirements.

• Experience with Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), Electronic Investigator Site Files (eISF), and related clinical research systems.

• Experience in supporting investigator site activation and regulatory documentation in sponsor or CRO settings.

• Familiarity with IRB and ethics committee processes and submissions.

• Experience utilizing Shared Investigator Platform and document exchange portals.

• Strong organizational, documentation management, stakeholder engagement, communication, problem-solving, and multitasking abilities.

• Proficient or advanced spoken and written English language skills.

• A quality-focused mindset with meticulous attention to detail and a commitment to compliance.

🏝️ Benefits

• 6-month temporary position.

• Flexible working arrangements.

• Continuous learning opportunities.

• Career advancement opportunities.

• A diverse, growth-oriented team environment.