Business Systems Analyst
- Contract Type
Main Responsibilities System Implementation ? Partnering closely with Client Services Lead in support of implementation of client Randomization and Trial Supply Management (RTSM) applications to enable client start-up targets; ? Attending client meetings and design sessions; ? Logging, tracking and driving resolution of functional and technical issues discovered during implementation and prior to go-live; ? Ensuring adherence to required deliverables and milestones of Project Management SOP; ? Driving project specific validation activities including study testing, system setup and implementation activities; ? Supporting system integration activities, including configuration and change control System Operations ? Developing, implementing and overseeing client communication plans, including service level agreements data management and support procedures, as per SOPs; ? Supporting Client Services Lead in supplies consulting and analysis required; ? Customer Support point of escalation for any system or support issues where required; developing training materials and train Customer Support staff on study application support procedures and client standards; ? Monitoring study issues for trends to enhancement opportunities or additional training needs; ? Developing client governance materials and participating in client business reviews; ? Participating in client audits Qualifications and Experience • A Bachelor’s Degree in a life science, supply chain management, an information technology field, or equivalent experience; • Minimum of 3 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation, or 7+ years of relevant system implementation experience in a related industry; • Software implementation and testing experience in clinical research or a supply chain related industry; • Project management experience working with cross-functional business and technical teams, preferably as project lead; • Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11; • Clinical supplies forecasting and management experience; • Supply chain certification or experience; • Experience with IRT/RTSM and clinical supplies forecasting/simulation tools; • Experience working with agile development methodology; • Candidates must possess excellent verbal and written communication skills in English. Any other language would be an asset; • Relevant working/residency permit or Swiss/EU-Citizenship required; • This position requires up to 25% business travel.
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