Clinical Trial Associate (F/H/X)

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Its capacity to develop high potential assets, from early-stages to late development and pre-commercialization stages, is illustrated through the successful 52-week readout of its Phase 3 trial (ELATIVE®) evaluating elafibranor in Primary Biliary Cholangitis (PBC). Today, GENFIT has a diversified R&D pipeline covering several therapeutic areas: five programs in acute on chronic liver failure (ACLF) are in clinical stages (Phase 2) and pre-clinical stages, including hepatic encephalopathy (HE), one of the main complications of ACLF; a Phase 2 clinical program targeting cholangiocarcinoma; and a preclinical program targeting urea cycle disorders (UCD) and organic acidemias (OA). GENFIT’s pipeline also includes a diagnostic franchise focused on Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis or NASH) and ammonia. GENFIT has facilities in Lille and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital. For more information, visit www.genfit.com

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).

With respect to recruitment, GENFIT commits to providing equal treatment to all applicants, regardless of gender, age, sexual orientation, ethnicity, race, citizenship, disability status, religion, or any other discriminatory characteristic under applicable laws. By choosing to apply for a position at GENFIT, you agree that fostering an inclusive and diverse work environment is our shared responsibility.