Company Description
PSI is an award-winning full-service CRO,bringing together more than 2,700 dynamicand knowledgeable individuals working to help impactthe future of medicine in more than 60 countriesaround the world.We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new medicines. Our work helps patientsin need improve their well-being – a fundamental driver for many ofus to show up and do our best eachday.
Job DescriptionIn this role, you will undertake activities to assess, plan and set up trial supply schemes for assigned projects and manage vendors involved in clinical supplies and interactive response technology.
Office-Based in Madrid or Home-based. You will: Analyze clinical trial protocols and translate requirements to establish an efficient supply chain solution for PSI studiesBuild and maintain a drug demand forecast in line with planned enrolments.Plan the optimal campaign strategy, to ensure clinical supplies are available in accordance with the project requirements.Manage the CMO vendor - oversee packaging, labelling, procurement, distribution and QP release activities to ensure supplies are delivered on time.Manage the IRT vendor - lead study specific system set-up, UAT, system acceptance and ongoing system updates.Develop clinical supply plans and provide input for the development of vendor management plansParticipate in the selection of trial supply vendors and IRT vendors for PSI studiesSupport and train PSI teams in clinical supply managementLiaise with PSI project teams, company divisions, clients and vendorsAssess risks associated with clinical product management and quality incidences reported by vendorsSupport business development tasks related to clinical trial supply servicesQualificationsCollege or University degree3-5 years' experience in Clinical Supply Chain Management (Essential)Experience working with supply chain technologies (i.e. IRT, CTMS, IWRS integration rules and principles)Training in GMP and GDPAbility to communicate effectively with vendors and internal partiesAbility to work both independently and in a team environmentPC skills to be able to work with MS Word, Excel and PowerPointAdditional InformationYou will work closely with driven and dedicated cross-functional teams, get all support and ownership of your projects. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
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