Within the Clinical Development Department, 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 (some knowledge of French is a plus);
• Travel may be required (up to 15%).