Clinical Trial Submissions Manager - Belgium, Germany
Function: The Clinical Trial Submissions Manager is responsible for the set-up and execution of clinical trial submissions to Ethical Commitees and Competent Authorities (during start-up, progress and closure). Other activities may include supporting reimbursement projects and CE-marking projects, all in compliance with the regulatory requirements throughout involved countries with reference to the relevant legislations, applicable guidelines and genae SOPs. He/She will be responsible for leading and guiding the team of regulatory associates to assure submissions are performed correct and within the expected timelines. Furthermore he/she will act as the subject matter expert for clinical teams and clients in terms of regulatory requirements and compliance as well as an intermediary between the different parties involved, which may include the genae Clinical Project Manager, Competent Authority, Notified Body, Health Insurance Agency, Ethical Committee and the client.
• Higher educational degree (BSc, MSc) in a medical or science-related field; pharmacy, nursing or equivalent, healthcare professional qualification preferred.
• Relevant experience in clinical research and clinical trial submissions
• Knowledge of applicable laws, regulations and guidelines related to clinical trials
• English and German or French and Dutch