Pre-clinical Project Manager

il y a 2 jours


Orsay, France Immutep Temps plein

Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France, Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and NASDAQ. Location: Berlin, Germany office based or home office, negotiable Summary: As a result of continuous progress in our projects we want to expand our team and therefore seek a Clinical Trial Associate. You will work closely with the Clinical Trial Supply and Vendor Manager and other team members to support the execution and maintenance of clinical trials within a global environment. Your responsibility includes support with vendor management oversight activities related to the IMP supply chain, and support clinical trials in general by maintaining organized files/eTMF, tracking/reporting, and communicating routinely with CROs and collaborators in the clinical research program. This implies the supporting of national and international projects under consideration of local laws, international guidelines (ICH GCP) and applicable SOPs. Job description: - Support the clinical team with tasks related to IMP management from start-up to study completion - Support with IMP vendor oversight - Responsible of tracking and reporting IMP trial-specific stock and support for other related activities of IMP supply chain - Assist with Clinical Trial documentation and contribute to clinical core documents mostly related to the IMP management (e.g. Pharmacy Manual, etc) - Providing overall support to the clinical team e.g. prepare presentations, status reports etc - Assist the clinical team interacting with CROs and collaborators - Responsible for the internal part of the trial master file (TMF) -Paper and electronic - Invoice tracking for Responsible team member review - Assist in Co-Monitoring visits, if applicable - Support preparation, conduct and follow-up of GCP audits and GCP inspections



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