Clinical Project Manager
il y a 1 semaine
You hold a Master’s degree (Bac+5), a PhD in clinical research, or an equivalent field of study.You have at least 2 years of experience in this role (within a CRO, pharmaceutical, or biotechnology industry).You have experience managing international clinical studies and working within multicultural teams.You ensure rigorous patient monitoring throughout the clinical study while adhering to protocol standards and the quality of collected data.You are familiar with the use of E-Consent tools to ensure an informed consent process compliant with regulatory requirements.You have strong communication skills and are capable of managing various projects involving multiple stakeholders.You have expertise in budget management, planning, project tracking, and logistical oversight of clinical supplies.You monitor KPIs defined with vendors to ensure timelines, budget, and quality are met.You develop and implement CAPA plans to resolve non-conformities.You have experience managing vendors, including contract research organizations (CROs).Experience in oncology is a plus, as is expertise in other therapeutic areas.You are fluent in English.Key Responsibilities:You oversee and manage all aspects of outsourced international clinical studies (interventional phases), including planning, quality, budgeting, and study objectives.You drive execution and reporting activities in collaboration with various clinical departments.You validate the project plan developed by the CRO in alignment with study goals and requirements, including roles and responsibilities, risk management plans, escalation processes, and communication plans.You ensure international clinical studies are conducted in compliance with Good Clinical Practice (GCP), local regulations, guidelines, and Standard Operating Procedures (SOPs), with the required level of quality.You communicate effectively on project progress and collaborate within a cohesive team.You lead and coordinate the cross-functional clinical team and CRO in partnership with other project team members.Who We Are:We are one of the world’s leading Contract Research Organizations (CROs), with the commitment, expertise, and flexibility required to successfully conduct clinical studies.We work with pharmaceutical, biotechnology, cosmetic, and other companies, offering them innovative and adaptable solutions.We operate in 10 countries across 3 continents, bringing together over 1,000 talented professionals committed to advancing clinical research.We have been part of the ALTEN Group since 2014 and are constantly exploring new opportunities to expand our global presence.Joining Aixial Group means:Being at the forefront of clinical research: You will work on cutting-edge projects where your expertise will be valued and have a real impact on the lives of millions.Continuously developing your career and skills: Our people are at the heart of everything we do. At Aixial Group, you will be mentored and supported throughout your journey to grow professionally and personally.Working in an environment where equality, diversity, and inclusion are fundamental: We strive to create a workplace based on dignity and respect, where individual differences are recognized and valued, and where every employee can thrive. Gender parity is central to Aixial Group’s growth strategy.Aixial Group is growing and continuously hiring in the field of clinical research. Join us #J-18808-Ljbffr
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