Clinical Trial Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78fw63

Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. La preghiamo di leggere attentamente la panoramica e i requisiti per questa occasione di lavoro riportati di seguito. 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.Job titleClinical Trial Manager for a maternity cover.OverviewThe 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.ResponsibilitiesParticipates in the CRO selection process and periodic CRO/vendor performance assessmentContributes to development of clinical study protocols, trial budgets and project plansContributes to country and site selection for clinical trialsAssists in planning and operational execution of clinical trial supply needsTakes responsibility in maintenance of clinical trial registries and related databasesServes as point of contact to CRO and vendorsMaintains a strong knowledge of the protocol and study proceduresReviews 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 levelDevelops and implements Vendor Oversight Management Plan (VOMP)Leads and/or supports preparation a

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78fw63