Remote Jobs at Keyrus Life Science North America

Main Tasks Study Set up and maintenance (e.g., creating, amending study in IRT based on protocol design, amendments, helping answering Helpdesk, central and local study teams on complex IRT questions/study operational situations on a day-to-day basis) Supporting Quality and processes (e.g., creating/updating SOP, guidelines, training materials, handbooks, delivering F2F IRT trainings to study stat, safety etc., responsible for all IRT related study documentation in eTMF from creation to archiving stage, regularization of legacy/non-documented processes) Supporting Study team as overall SME for IRT tool, randomization, blinding/un-blinding (e.g., continuously supporting study statisticians, trial supply managers and other central functions from concept protocol design to logistical & supply strategy design to protocol amendment, study operational manual, providing inputs to quality incidents /CAPAs, FSO study setup, attending IT meetings as IRT business owner pushing on improvements, ...