Your Mission
* You plan, implement and maintain a system of global standard operating procedures for clinical operations to ensure that the health of study participants is protected and that all department activities comply with Good Clinical Practice and global regulatory requirements and legislation
* You assess, plan, coordinate and implement the digitalization of global clinical operations processes and support initiatives to drive operational efficiency and excellence
* You ensure that KARL STORZ sponsored medical device studies are planned and conducted according to the latest science and methodology, including innovative clinical research approaches and real world evidence
* In collaboration with Clinical and Medical Affairs, you drive the development of clinical trial protocols and associated clinical documents required for regulatory submissions
* You manage the day-to-day operations of your assigned studies, such as site recruitment, investigator meetings, training, problem solving, quality assurance tasks and timely closure
* You evaluate, select and manage clinical providers/suppliers (e.g. contract research organizations (CROs), central laboratories/readers)
* You communicate effectively with investigators and site staff to implement clinical trial protocols and support study enrollment and conduct objectives
* You represent Clinical Operations in a matrix environment through regulatory and scientific expertise and organizational influence and promote a patient-centric and data-driven mindset across the global KARL STORZ organization
Your Talents
* Master's degree in a life science or medical degree program or comparable degree
* Certified ICH-GCP and/or EN-ISO-14155 training and in-depth knowledge of relevant global regulations for clinical research with medical devices (e.g. EU-MDR, EN-ISO-14155, US-FDA-PMA and post-approval studies)
* Experience in writing and managing standard operating procedures, templates and forms and conducting audits with regulatory authorities
* At least 5 years of hands-on experience in planning, conducting and managing industry-sponsored clinical trials for regulatory purposes, ideally with global reach
* Hands-on experience with modern clinical research designs and methods, clinical trial management systems and electronic data capture
* Self-motivated, assertive and able to work independently and as part of a team
* Good written and verbal communication skills and efficient and detail-oriented way of working
* English language skills required, German language skills an advantage
* Willingness and ability to travel up to 30%