Clinical Trial Associate

Clinical Trial Associate

GENFIT

Lille, France

Within the Clinical Development team, the Clinical Trial Associate (CTA) supports clinical and operational activities.

MISSIONS:

Your responsibilities include, but are not limited to:

• Assisting the Clinical Team in the preparation, handling, distribution, filing, archiving, and tracking of clinical documentation and reports;
• Accurately organizing the electronic trial master file (eTMF): filing essential documents in the study eTMF, verifying the quality of the documents and preparing periodic completeness reports;
• Maintaining internal trackers for clinical trial activities and study documents;
• Serving as a Clinical Operations administrative point of contact for internal stakeholders and external vendors (including Contract Research Organizations);
• Using various vendor systems to provide metrics and administrative support as needed;
• Participating in the development of internal processes and procedures;
• Representing the Clinical Operations Team for designated project communications, correspondence and associated documentation;
• Organizing and participating in internal team meetings, including drafting agendas and minutes.

PROFILE:

• You hold a minimum of a bachelor’s degree, ideally in life sciences;
• You have least 3 years of experience in clinical research in a biopharmaceutical company and/or CRO: your experience within the industry has enabled you to develop a solid knowledge of ICH and GCP;
• You have extensive experience with Microsoft Word, Excel, PowerPoint, and clinical trial management systems;
• You thrive in a fast-paced, international environment and you have the autonomy, flexibility and adaptability to work in a biotech company;
• You have demonstrated your ability to establish and maintain effective working relationships with cross-functional team members, leaders, and external partners;
• You possess excellent organizational skills and attention to detail;
• You are fluent in English (B2+ level minimum), with excellent written and verbal communication skills (some knowledge of French is a plus).

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