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OPERATIONAL EXCELLENCE MANAGER

Descripción de la oferta de empleo

Who we are?Exeltis is part of the Spanish multinational Insud Pharma, which has a track record of over 40 years and a team of 9,000 professionals worldwide. Insud Pharma is present at every level of the chemical and pharmaceutical industry through its three highly-synergistic business units: industrial (Chemo), brand (Exeltis) and biotechnology (mAbxience). Our overarching goal is to protect and improve people’s health and wellbeing.Global ResponsibilityThe Operational Exellence Manager will be responsible for the strategic and operational management of clinical trials from planning through completion. This role ensures that clinical studies are conducted on time, within budget, and in compliance with regulatory standards (ICH-GCP).Key Responsibilities:Resource Planning: Manage and allocate resources for clinical trials, ensuring optimal availability of personnel and other necessary resources.KPI Creation and Review: Establish and monitor key performance indicators (KPIs) to assess the progress and success of clinical trials.Team Management: Serve as the line manager for Clinical Team Leads (CTLs), Site Managers, and Recruitment Coordinators, fostering a collaborative team environment.Risk Assessment and CAPA Plans: Oversee the development and implementation of risk management plans, co-monitoring visits, and Corrective and Preventive Action (CAPA) plans.Manual and Plan Review: Approve and review key documents such as operational manuals, monitoring plans, and working guidelines.Onboarding Process: Design and execute the onboarding process for new employees and vendors within the clinical operations area.Ethics Committee (EC) Submissions: Supervise submissions to Ethics Committees to ensure regulatory compliance.Requirements:Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.Minimum of 5 8 years of experience in clinical trials, including experience in team management and oversight of Contract Research Organizations (CROs).Advanced knowledge of ICH-GCP and FDA regulations.Previous experience managing and monitoring clinical trials across multiple phases (I-III).Exceptional leadership, problem-solving, and project management skills.Ability to travel up to 20% based on project needsKey Competencies:Ability to work under pressure in dynamic environments.Excellent interpersonal and communication skills.Proven ability to manage multiple projects simultaneously while meeting deadlines.Analytical skills to track KPIs and recommend improvements as neededThis role offers the opportunity to directly influence the success of global clinical trials and contribute to the development of innovative treatments. If you are passionate about clinical research and team leadership, we encourage you to apply!
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Detalles de la oferta

Empresa
  • Exeltis
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 06/10/2024
Fecha de expiración
  • 04/01/2025
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