Site Activation Partner – FSP

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

📋 Description

• Oversee and manage site activation activities along with essential document handling to ensure timely site initiation and study start-up.

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

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

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

• Work alongside study teams and supporting functions to reach site activation and operational milestones.

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

• Coordinate document translation tasks with authorized vendors.

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

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

• Aid in preparation for audits and inspections, as well as responses to them.

• Identify, address, and escalate site-related challenges while supporting corrective and preventive measures.

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

⛳️ Requirements

• Bachelor's degree.

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

• Understanding of clinical trial methodologies, ICH/GCP standards, FDA regulations, and applicable 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.

• Background in supporting investigator site activation and regulatory documentation within sponsor or CRO environments.

• Familiarity with IRB and ethics committee procedures and submissions.

• Experience utilizing Shared Investigator Platform and document exchange portals.

• Strong skills in organization, documentation management, stakeholder engagement, communication, problem-solving, and multitasking.

• Proficient or advanced spoken and written English language skills.

• Quality-focused mindset with a keen attention to detail and a commitment to compliance.

• Ability to collaborate with global teams and communicate effectively with investigator sites and study stakeholders.

🏝️ Benefits

• Temporary role for 6 months.

• Work-from-home arrangement.

• Flexible work environment.

• Opportunities for growth and continuous learning.

• Career advancement and expanded expertise in clinical research operations.