Coordinador de Suministros y Logística

Parexel busca un Coordinador de Suministros y Logística (Supply and Logistics Coordinator) para trabajar de forma remota en Argentina. El rol implica dar soporte a la estrategia de cadena de suministro para ensayos clínicos, incluyendo el abastecimiento y la distribución de suministros, asegurando el cumplimiento de plazos, presupuestos y estándares de calidad.

Descripción del puesto

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Supply & Logistics Coordinator (SLC)/Senior Supply & Logistics Coordinator (SrSLC) is responsible for supporting the development and applying the study specific supply chain strategy including the sourcing and distribution strategy for clinical trial supply to ensure that complex clinical logistics projects are set up and executed according to timelines, budgets, quality standards, SOPs and applicable ICH-GxP* and other applicable industry and regulatory guidelines to meet or exceed client expectations. Key Accountabilities : Project Planning Clinical Trial Supply Strategy Support the development of the project specific supply chain strategy incl. sourcing and distribution Utilize applicable tools for supply chain simulation and forecasting Plan and monitor inventory according to strategy, quantities and forecast Support risk analysis Develop supply schedule and provide feedback to depots Defines with regional peers material specifications regarding amount, lead times, local authorization, bill of material for project and kits Utilizes available data regarding countries, sites, and enrolment data for appropriate planning and strategy Set-up and maintenance of inventory management systems (e.g. IVRS, IPtrack, etc). Perform UAT in close cooperation with e-Logistics team. Provide input into development of documents, manuals and quality documentation including GMP relevant documentation. Develop and plan inventory according to meet required strategy, quantities and forecasts Suggest and implement problem resolutions to meet required timelines. (Senior) Support programs and assets Project Execution and Control Keep oversight of the progress of the trial and coordinate with CSL requirements Support development of logistics concepts Support development of required study documents and systems according to project timelines and resources As needed, represent Clinical Logistics Services at client and internal project meetings Comply with Quality standards, including applicable SOPs and GxP* standards Perform key accountability tasks for Clinical Trial Supplies (IMP and Non-IMP) and for Ancillary Supplies Complaint handling following GxP guidelines Support coordination of purchasing, manufacturing, distribution, return, recall and destruction of medication for clinical trials, as applicable Incorporate the implications of local licensing and registration of medical devices for distribution process and supply chain Supports Technical Logistics Coordinator in development of specific technical solutions Collection of document and QC on printability Performs QC on print product received and releases print runs (Senior) Support programs and assets Customer Satisfaction and Client Liaison Proactively engage external and internal clients in solution improvements Ensure study/project timelines, budgets and efficiencies are met If requested actively take part in the bidding process (Proposal, 3rd Party Vendor Selection, Bid Defense, Contracts negotiation and review) including client presentations If requested represent Parexel at professional meetings/ conferences as participant and/or speaker Assist in managing increased demands and expectations of customers through consistency and predictability in internal procedures and avoidance of crisis situations Ensure Quality and Process Improvements Develop reports and statistics for studies and department Support ongoing optimization of system infrastructure (systems used by CTS&L such as IPTrack, processes, PRXL internal tools) Address and follow up on quality issues and implement CAPA Collaborate with preparation and participate in and follow up on audits/inspections Accountability Supporting Activities Implement process improvements, in conjunction with the team, in response to corporate, quality, client and team feedback and quality audits (Senor) Identify and initiate process improvements Menor Clinical Supply Coordinators and Clinical Supply Specialists Skills: Ability to lead and build rapport with a culturally diverse group at multiple levels and disciplines  Strong client focus Strong demonstrated ability to conduct business in English (written and spoken) and in local language if different from English Good/Very good understanding of the drug development regulatory framework Good/Very good knowledge of Microsoft Office programs (Word, PowerPoint, and Excel) Multi-tasking and prioritization ability Result-oriented, confident, self-motivated, and driven/high energy Solid communication (verbal & written) and negotiation skills Ability to influence and gain collaboration from and respect of key stakeholders Flexible, capable of managing change and ambiguity Good/very good analytical capabilities combined with creative problem-solving skills and a sense of urgency Basic/Profound Project Management skills Knowledge and Experience : Great/Extensive experience in clinical logistics or related field within the biopharmaceutical industry Leadership experience Experience/Profound experience in clinical supply chain management incl. IMP and non- IMP or related field within the biopharmaceutical industry Basic/Good understanding of financial tasks such as budgeting, revenue recognition, PTC, invoicing Experience/Good Experience in Packaging, Labeling and Distribution of (Non-) IMP Multinational work experience Fluent in English (Senior) Good Leadership experience Education: Bachelor or Master Degree, or equivalent (e.g. Pharm. D.), in biology, pharmacy, or other health- related discipline, international trade or logistics business or relevant work experience /degree.

Responsabilidades

• Desarrollar y aplicar la estrategia de cadena de suministro específica del estudio.
• Gestionar el abastecimiento y la distribución de suministros para ensayos clínicos.
• Planificar y monitorear inventario según estrategia, cantidades y pronóstico.
• Realizar análisis de riesgos y desarrollar cronogramas de suministro.
• Configurar y mantener sistemas de gestión de inventario (ej. IVRS, IPtrack).
• Realizar pruebas de aceptación de usuario (UAT).
• Proporcionar información para el desarrollo de documentos y manuales de calidad.
• Sugerir e implementar soluciones para cumplir plazos.
• Coordinar la compra, fabricación, distribución, retorno, retiro y destrucción de medicación para ensayos clínicos.
• Colaborar en la preparación y seguimiento de auditorías/inspecciones.
• Implementar mejoras de procesos.

Skills requeridas

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