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Join the Aurealis Therapeutics team
Our team is expanding! On this page, you can learn more about our open positions:
Clinical Project Manager
As a Clinical Project Manager, you are responsible for the planning, preparation, execution, and management of clinical studies according to the required quality standards, on schedule, and within budget. You will oversee and manage the activities of CROs and are responsible for the preparation of relevant clinical documents (Clinical study protocols, manuals, IB, IMPD, CTA, design of eCRF). Your primary task is to manage our product AUP-16 phase 1-2A clinical studies in venous leg ulcer, pressure ulcer, and/or other non-healing wounds.
As a Medical Monitor, you are responsible for medical and safety aspects of clinical development, advising and consulting on safety event evaluation, providing physician-level opinions on multiple trials and sites, consulting on protocol design, patient safety concerns, deciding if a specific adverse event requires unblinding, mediating between sponsor, CRO and trial sites, reviewing whether concomitant medications and adverse events are coded and reported properly, examining the protocols of a clinical study, planning and initiating a trial, and dealing with the data (analysis, interpretation, exploration). You are also responsible for pharmacovigilance/drug safety (Drug Safety Officer).