Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. Our proprietary viral vector platform has the capacity to encode for large payloads of neoantigens or other immunomodulators and is clinically demonstrated to safely and potently harness the power of the immune system. Competenze, Esperienza, Qualifiche: se possiede i requisiti giusti per questa possibilità, si candidi oggi stesso. Job title Clinical Trial Manager for a maternity cover. Overview The Clinical Trial Manager directs and/or supports the planning and conduct of clinical trials (phase I to III), in-house and outsourced to a Contract Research Organization (CRO), in compliance with company processes, ICH-GCP and regulatory requirements. Responsibilities include CRO management and vendor oversight of outsourced activities, coordination and participation in co-monitoring of clinical trials, and performing assigned responsibilities to ensure timely achievement of departmental goals and objectives related to clinical trials.
Responsibilities Participates in the CRO selection process and periodic CRO/vendor performance assessment Contributes to development of clinical study protocols, trial budgets and project plans Contributes to country and site selection for clinical trials Assists in planning and operational execution of clinical trial supply needs Takes responsibility in maintenance of clinical trial registries and related databases Serves as point of contact to CRO and vendors Maintains a strong knowledge of the protocol and study procedures Reviews and prepares study plans and manuals (Patient Information Sheet and Informed Consent Form, Project Plan, Monitoring Plan, Communication Plan, Pharmacy Manual, Investigator Site File, etc.) Approves country/site PIS/ICF prepared by CRO and oversees timely PIS/ICF implementation on site level Develops and implements Vendor Oversight Management Plan (VOMP) Leads and/or supports pr
📌 Clinical Trial Manager (Italia)
🏢 Altro
📍 Italia