Clinical Project Manager

GENFIT

Lille, France

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%).

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