Clinical Research Manager (US)

Your responsibilities Cultivate a portfolio of clinical research projects and a network of clinical research sites and investigators to support Medartis business and regulatory requirements Create new and maintain existing customer contacts to include visits, trainings and advice acting as the point of contact between internal and external partners Create new and maintain existing processes within the Medartis quality system ensuring that all processes comply with internal and external regulatory and legal requirements Select and support preclinical and clinical studies (including patient registries, retro- and prospective studies, case study reviews, pre-clinical modeling, possible PMA studies, etc.) by proactive engagement of study institutions and clinical researchers to participate in studies directing communication with the study director from the conception phase until publication of the final report, providing support with writing of study protocols contractual questions and follow up as required regulatory requirements (lRB, ethics committees, ICH-GCP, ISO 14155, SAE reporting) statistical analysis and scientific writing (written reviews for publication/ presentations) implementation of digital tools such as databases, EDC solutions, registries, (e)CRFs, etc. and training of study staff (nurses, PIs, etc.) on said tools supplying study hardware coordination with CROs preparation and maintenance of TMF and ISF support of study site(s) and study nurse(s); e.g., with que