Regulatory and Start Up Specialist

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

📋 Description

• Execute responsibilities at a national level related to Site Activation (SA) initiatives.

• Act as the Single Point of Contact (SPOC) for investigative sites within assigned studies.

• Ensure compliance with standard operating procedures (SOPs) and Work Instructions (WIs).

• Carry out start-up and site activation tasks in accordance with relevant regulations.

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

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

• Guarantee the precise completion and upkeep of internal systems and databases.

• Review and offer feedback to management regarding site performance metrics.

• Assess, establish, and agree on project planning and timelines.

• Ensure that monitoring measures are implemented and that contingency plans are enacted as necessary.

• Notify team members upon the completion of regulatory and contractual documents.

• Review, track, and follow up on the progress, approval, and execution of documents.

• Provide localized expertise to SAMs and the project team during the initial and ongoing project timeline planning.

• Conduct quality control of documents submitted by sites.

⛳️ Requirements

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

• 3 years of clinical research or relevant experience; or an equivalent combination of education, training, and experience.

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

• Knowledge and capability to apply GCP/ICH and relevant regulatory guidelines.

• Familiarity with applicable 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.

🏝️ Benefits

• Home Based opportunity.

• French language fluency required.