Start Up Specialist - Fluent in Hungarian

About this role

Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues we grow we are seeking a Start Up Specialist to join our growing team. For this position, we are open to candidates at all levels, who have acquired some Site Start Up experience gained from within a Clinical Research Organisation. We are open to candidates located in Hungary, Poland, Serbia, Slovakia or Romania with fluency in Hungarian. Essential functions of the job include but are not limited to: Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. Customize country/site specific Patient Information Sheet and Informed Consent Form. Responsible for/facilitates the translation and co-ordination of translations for documents. Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. span style="font-family: arial, helvetica,

The employer's own description, as posted on their site. Apply on Precision Medicine Group's site ↗