Business Analyst
генерация резюме под вакансию
сопроводительное письмо
описание
The clinical supply chain systems team supports technology platforms for clinical trial planning, manufacturing, distribution, inventory management, and trial supply execution.
задачи
- Partner with Clinical Supply Chain, Clinical Operations, Manufacturing, Logistics, Quality, and Regulatory stakeholders to understand business requirements;
- Facilitate workshops, process mapping sessions, and requirements gathering activities;
- Translate business needs into detailed functional and technical requirements;
- Document business processes, workflows, user stories, use cases, and functional specifications;
- Serve as the subject matter expert for clinical supply chain business processes;
- Support and enhance clinical supply chain technologies, including RTSM/IRT, CTSM, and ERP platforms;
- Analyze system performance and identify optimization opportunities;
- Support system configuration, testing, validation, and deployment activities;
- Ensure system capabilities align with evolving business requirements;
- Participate in implementation and upgrade projects for clinical supply systems;
- Develop BRDs, FRS, and process flows;
- Coordinate UAT activities;
- Support change management and stakeholder adoption initiatives;
- Collaborate with vendors, consultants, and cross-functional project teams;
- Support clinical demand planning, drug forecasting, inventory management, depot and site resupply, packaging and labeling, manufacturing planning, distribution and logistics, and temperature-controlled supply management;
- Analyze operational metrics and identify process improvement opportunities;
- Ensure systems operate within GxP and regulatory requirements;
- Support CSV activities;
- Maintain audit-ready documentation;
- Collaborate with Quality and Validation teams during inspections and audits;
- Develop and maintain operational reports and dashboards;
- Analyze clinical supply chain data to support decision-making;
- Monitor inventory levels, forecast accuracy, drug wastage, stock-out risk, and supply chain performance KPIs;
- Support data integrations across clinical and enterprise systems.
требования
- Bachelor's degree in Information Systems, Computer Science, Supply Chain, Life Sciences, or a related field;
- Previous experience as a Business Analyst, Systems Analyst, or Functional Analyst;
- Experience supporting clinical supply chain or clinical trial operations;
- Strong understanding of clinical trial supply management processes;
- Experience with RTSM/IRT platforms;
- Experience with ERP systems such as SAP or Oracle;
- Strong requirements gathering and documentation skills;
- Experience facilitating workshops with business stakeholders;
- Excellent communication and stakeholder management skills;
- Nice to have: experience in pharmaceutical, biotechnology, CRO, or clinical research organizations; SAP S/4HANA; SAP IBP; Oracle Fusion; Medidata RTSM; Suvoda IRT; Oracle Clinical One; Veeva Vault; Power BI; Tableau; GxP, FDA, EMA, and ICH regulations; Agile and Waterfall methodologies; CBAP, PMI-PBA, or equivalent certification.
условия
- Contract employment;
- Work location: European Union.
навыки
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