Main Responsibilities Manage clinical studies under scientific and legal guidelines, in collaboration with the project leader Prepare, conduct and follow-up on site evaluation , site initiation, site monitoring, and site close-out of the involved clinics (on-site and remote) Assures adherence to GCP, investigator integrity and compliance with all study procedures through the monitoring phase Make short and long-term plans to monitor involved clinics to ensure data quality and compliance Prepare, develop, and submit documents for public authorities and/or ethics commission submissions Develop and adapt Case Report Forms (CRFs) Control quality and collection of clinical data Update Project Managers regarding the documentation quality of the clinics and report regularly on the general status of the participating site Prepare and implement solutions, in collaboration with the project leader or Head Clinical Operations,to maintain or adapt the project timelines, budget and scope Maintain contact with Principal Investigators and Study Coordinators and provide them support to conduct the clinical investigation Conduct regular trainings for study sites to ensure data quality and regulatory compliance within the clinical investigation Prepare and develop Study Newsletters and annual reports as requested by the Project Manager Clinical Operations Prepare clinical data for analysis in collaboration with the project team, including Project Coordinator, Data Manager and Medical Statistician Assist in optimizing quality standards and SOPs Prepare, assist and coordinate contract negotiations The employee performs all tasks in alignment with the requirements of the ISO 9001 quality management standard and actively contributes to maintaining and improving the quality system The employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System
Benefits
