Madrid Clinical Operation Project Manager FM Madr 28043

Job description

We are an international and independent pharmaceutical group with a human scale, governed by a Foundation. Our unique model is our pride but, above all, it enables us to fully serve our vocation: “Committed to therapeutic progress for the benefit of patients”. A global leader in cardiology today, we have chosen to become a focused and innovative player in oncology by 2030, by targeting hard-to-treat cancers and dedicating more than 70% of our R&D budget to them. This is a challenge we are pursuing alongside the development of our generic business to ensure access to quality healthcare for all, at a lower cost. Who are we? 22,000 passionate employees of more than 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, with and for our teams, driven by the desire to care, to dare, to develop, and to commit ourselves to being useful to those who need it. Come and experience our commitment, and help us bring it to life #MovedByYou www.servier.com We are seeking a Clinical Operation Project Manager to lead and oversee clinical trial activities in Spain. In this role, you will be the key driver for ensuring that our Phase I-III studies are executed with the highest quality, scientific standards, and regulatory compliance. Your Mission As a Clinical Operation Project Manager, you will manage the operational lifecycle of clinical trials, from feasibility to site closure. You will act as a link between the company, CROs, and external stakeholders to ensure study execution. Key Responsibilities Regulatory and Compliance Ensure all local regulatory requirements and ethical codes are strictly followed. You will work closely with CROs to prepare submission files for Regulatory Authorities and Ethics Committees, ensuring timely responses to all inquiries. Operational Oversight Lead country and center feasibility assessments. You will supervise the local management of Investigational Medicinal Products (IMP) and oversee the entire site lifecycle, including start-up, equipment needs, and closure. Coordination and Training Organize and coordinate training for investigators and site personnel, including Local Investigator Meetings and Site Initiation Visits. You will also ensure the internal study team receives technical, study-specific training. Quality and Risk Management Verify that studies meet planned quality and scientific standards. You will be responsible for setting up corrective actions, answering audit findings, and providing full support during inspections by Regulatory Authorities. Stakeholder Management Liaise with Quality Assurance and Pharmacovigilance managers to implement updated guidelines. You will also serve as a scientific link between subsidiaries and Therapeutic Areas, maintaining regular contact with experts and Opinion Leaders. Required Skills and Experience Education A Bachelor’s degree in Life Sciences or an equivalent field is required. Professional Background You must have a minimum of 5 years of experience in clinical research, including at least 2 years specifically in clinical project management or clinical operations management. A background as a Clinical Research Associate (CRA) is required. Clinical Expertise Demonstrated experience managing Phase I-III clinical trials is essential. Specific experience in Oncology, Hematology, or Neurology is highly preferred. Technical Knowledge Solid knowledge of ICH-GCP, clinical trial processes, and applicable regulatory requirements. You should be experienced in managing study metrics, KPIs, budgets, and risk management at a national level. We are committed to equal opportunity and the development of talent in all its diversity. We value experience as much as the desire to commit daily to being useful to therapeutic progress for the benefit of patients. If you recognize yourself in this offer and these few lines, take this opportunity to meet us. Enviar candidatura ahora » Buscar ofertas de trabajo similares: TÉRMINOS DE USO GESTIÓN DE COOKIES @2022 LABORATORIOS SERVIER Responsable de consentimiento de cookies Cuando visita cualquier sitio web, puede almacenar o recuperar información en su navegador, principalmente en forma de cookies. Debido a que respetamos su derecho a la privacidad, puede optar por no permitir algunos tipos de cookies. Sin embargo, bloquear algunos tipos de cookies puede afectar su experiencia en el sitio y los servicios que podemos ofrecer. Cookies necesarias Estas cookies son necesarias para utilizar este sitio web y no pueden deshabilitarse. 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