Clinical Project Manager (F/H/X)

GENFIT is a late-stage biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated with the success of the 52-week Phase 3 ELATIVE® study evaluating elafibranor in Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com

Within the Clinical Development team, the Clinical Project Manager (CPM) manages aspects of a clinical study, such as overseeing investigational sites and CRO site management, leading vendors, and/or performing centralized monitoring of clinical data.

MISSIONS:

Your responsibilities include, but are not limited to:

Proactively managing operational aspects of clinical projects;
Ensuring clinical studies are conducted according to the study protocol, SOPs, ICH/GCP regulations, and study-specific manuals and procedures;
Contributing to the preparation of clinical documents such as protocols, informed consent forms, and study plans, guides, and manuals;
Participating in the development of clinical parts of regulatory documents, such as the IND, IB, and briefing documents;
Reviewing and managing study metrics, Key Performance Indicators, and Quality Tolerance Limits;
Reporting quality issues, contributing to the set-up of appropriate actions or CAPAs and following up until resolution;
Providing regular clinical trial progress reports to the Clinical Team Leader;
Supporting study feasibility assessments;
Leading site management activities for assigned sites:
- Assisting with the identification and selection of investigational sites and supporting the sites for start-up and throughout the study in close collaboration with the site monitor;
- Working consistently with selected investigational sites within a country or region to build and maintain strong relationships with investigators and their site study teams;
- Conducting / attending on-site visits as needed (Site Initiation Visits, Quality Control Site Visits, etc.);
- Identifying site barriers for study participant recruitment; proposing solutions;
- Assessing the performance of site monitors and CRO / vendor deliverables, addressing quality issues with the appropriate team members and identifying opportunities to improve training;
- Reviewing site visit reports, tracking site oversight activities, and following up to ensure resolution of site issues in a timely manner;
- Identifying and escalating site risks to the Clinical Team Leader and other stakeholders as appropriate;
Leading vendor management activities for assigned vendors, such as the central laboratory:
- Assisting in the identification and selection of appropriate vendors;
- Assisting with vendor training on protocols and procedures;
- Overseeing the performance of vendors; regularly reviewing metrics;
- Identifying and escalating vendor risks to the Clinical Team Leader and other stakeholders as appropriate;
- Managing vendor contracts and budgets, and reviewing payments;
Performing study inspection readiness activities, including the filing and QC of study documentation in the TMF according to the TMF index, SOPs/TMF plan, and all regulatory requirements and overseeing the CRO and vendors regarding TMF filing;
Participating in the development, review, and training for SOPs.

PROFILE:

You hold a minimum of a bachelor’s degree with a medical or scientific background; an advanced degree in a medical or scientific field is preferred;
You have least 3 years of experience in clinical trial management, including CRO / vendor oversight;
An experience in rare disease and/or with early phase development studies is a plus;
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 anticipate and resolve conflicts/issues, be proactive, and prioritize;
You have a good knowledge of ICH GCP, applicable ICH Guidelines, and 21 CFR;
You possess excellent organizational skills;
You are fluent in English (B2+ level minimum), with excellent written and verbal communication skills; a similar command of French, German and/or Spanish is a plus;
Travel may be required (up to 15%).

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.