Rhône, Auvergne-Rhône-Alpes, France
Pharma and CRO Client Management: • Serve as the primary point of contact for the company’s Pharma and CRO clients throughout their clinical studies • Develop and implement project planning (schedules, milestones, resources, budget, etc.) • Organize and lead project review meetings with Pharma and CRO clients • Monitor and communicate project progress (preparation, deployment, training, etc.) • Manage interactions between Pharma/CRO clients and internal company stakeholders (sales administration, logistics, training, service, etc.) Trial Project Management: • Lead the clinical study initiation process (Start-Up process), including site qualification and selection, implementation of monitoring tools, organization of kick-off meetings and project reviews • Coordinate and oversee deployment, training, and servicing of FibroScan devices and other services, with support from various departments (sales administration, logistics, training, service) as well as company partners and distributors • Ensure follow-up and engagement of required Echosens teams at both global and local levels (subsidiaries, distributors) Clinical Sites Management: • Manage interactions with clinical sites at all project stages, from site qualification to closure, including activation, equipment deployment, training, and organization of clinical services • Document site management activities
Clinical Logistic Supply Manager For Servier : - Participate in the setting up, follow-up and closure of clinical trials (oncology and immunology international studies) - Ensure the selection of CROs involved in the study (Central Lab, medical imaging, material, eCOA…) - Management of CROs involved in the study from study start-up to study close-out - Responsible for internal kick-off meeting, scope of work writing and budget estimation concerning vendors activities - Review of documents during the study start-up : Protocol, informed consent form, CROs documents - Prepare and participate to internal and external meetings with teams (Bid defense meeting, kick-off meeting, weekly meeting …) - Budget follow up and amendment if required, - Review, tracking and validation of invoices -Main contact for logistic activities (Study team, Finance, data management team, CROs, local team, sites) -Samples management - eTMF filling
Be the preferential contact point for the promotor when a new study is proposed to our Unit Take part the Pre Screening visits along with the Investigator, to control our capacity to participate to the Study (in terms of equipment/lab tests etc) Present to the promotor our procedures to open a new study at Gustave Roussy (Each Committees/Necessary documents/Key contacts) Transmit any necessary document to submit the study to the Health Authorities (CV/GCPs/Site suitability template etc) Present any new study to the Early Phase Committee and participate to the prioritization discussion depending on the study status toward the Health Authorities (Awaiting approval/Approvals obtained), its interest for our patients (do we already have another study with the same target, the same population?) Handle the study feasibility Contact each concern hospital service (laboratory/pharmacy/biopsy/ to ensure their ability to perform every exams required by the protocol And if necessary, create with them new working collaboration to suits the protocol requirement Coordinate the study between the Start up, the budget team and the operational team Maintain the study trackers up to date during its progression and until the Study Visit Initiation Be the point of reference for any Study with an advanced therapy medicinal product (Cell therapy/GMO/Oncolytic Viruses) All the above was also done for 6 months in the Advance Phases Haematology department 145 Studies in Start up of which 45 SIV
Organize the Study Initiation visit with the Promotor and the Investigator 2 SIV done) Assist the investigator for each new patient inclusion Collect, verify, and input the study data from the original source information Organize the monitoring visit and assist the monitor during those visits Declare and follow up any Serious Adverse event Take part in the Sponsor conference call Ship any study material (biopsy/blood/images etc Prepare and participate in the audit 1 Audit in 2020 Ensure the study close out and prepare documents for archiving 5 Studies Closed) Take part in the setup of cross departmental projects 2 Cell Therapy Projects the firsts of the Early Phases Department) 9 studies managed
Production of mutated virus in BSL 3 (Bio Safety Level) condition), Track the disease evolution in the animal model (Lung Cancer) Treat the animal with IL 2 injection Results presentation during the team meeting Supervisor of the BSL 2 laboratory Team training to Health and safety and good Practice to gain lab access Control of new protocol proposition according to the safety level and available equipment Supplies Stock Management Team Planning management Maintenance Management
Observation of mice under HFD (High Fat Diet) during several weeks, Intraperitoneal glucose tolerance test on these mice. Organs extraction, fixation and paraffin inclusion, in order to observe immune cells infiltrations in the different organs after the diet. Immune gene expression analysis from mice tissue thanks to qPCR. Participation to a human liver study by analysing CD8 and granzymes infiltration in these livers with fluorescent colorations.