Study Start-Up Specialist

Regulatory & Start-Up Specialist

Location: Paris, France (Remote with flexibility)

Employment Type: Full-time, 8 month contract

We are currently partnering with a leading global clinical research organisation to recruit a Regulatory & Start-Up Specialist for an exciting project within their Clinical Operations team.

This role is based in Paris, France, with remote working flexibility. This is an excellent opportunity to join a globally recognised CRO supporting complex and impactful clinical trials across multiple therapeutic areas.

The Role

As a Regulatory & Start-Up Specialist, you will perform country-level Site Activation (SA) activities in compliance with applicable local and international regulations, SOPs, project requirements, and contractual/budgetary guidelines.

You will act as a key liaison between investigative sites and cross-functional teams, ensuring timely and compliant site activation and regulatory submissions.

Key Responsibilities

• Act as Single Point of Contact (SPOC) for investigative sites, Site Activation Managers (SAMs), Project Management teams, and internal departments for assigned studies
• Perform start-up and site activation activities in accordance with applicable regulations, SOPs, and work instructions
• Prepare, review, and quality-check regulatory documents for completeness and accuracy
• Track and follow up on regulatory submissions, ethics approvals, Informed Consent Forms (ICFs), Investigator Pack (IP) release documents, and contracts to ensure adherence to timelines
• Maintain accurate internal systems, databases, and tracking tools
• Review site performance metrics and provide feedback to management
• Contribute to project planning and timeline management
• Implement monitoring measures and contingency plans when required
• Provide local regulatory expertise to project teams
• Engage with sponsors on specific initiatives where required

Candidate Requirements

Education & Experience:

• Bachelor’s degree in Life Sciences or a related field
• Minimum 3 years’ clinical research experience
• At least 1 year in a leadership, coordination, or oversight capacity
• Equivalent combination of education and experience considered

Knowledge & Skills:

• Strong knowledge of GCP/ICH and French/EU regulatory requirements
• In-depth understanding of clinical systems, procedures, and corporate standards
• Solid knowledge of the drug development process and regulated clinical trial environment
• Excellent communication and negotiation skills
• Ability to work independently and manage multiple projects
• Strong attention to detail and organisational skills
• Ability to build and maintain effective working relationships

If you are an experienced regulatory/start-up professional looking for your next opportunity within a global CRO setting, we would be pleased to speak with you.