Provide operational expertise and support to major transfomations and performance processes

- Planning & FTE management for clinical trials & project activities with Clinical users & platform heads- Ensure plan consistency across trials planning & FTE - Analyse and Resolve Demand vs Capacity gaps with global and local managers - Propose new way of working in process, standard definition, Metrics adjustements across trials and functions- Simulate in Tempo for evaluation study design & metric & FTE & timelines scenario

- Evaluate global strategies enhancement & budget activities (FTE & external costs) with IS R&D & SML head- Lead initiatives: Develop (Functional specifications & UAT), Implement, communicate, train and roll out - Lead global super user network to ensure standard way of working in all regions- Identify new business needs to manage the continuous improvement tools & associated functions processes- Set up data (creation / update investigators, countries, sites and design studies) of Clinical studies- Acts as Europe super user to support and train internal & external users and proactively assist in issue resolution

- Lead RFP & Kick off meeting with Clinical team members and Provider- Lead POC meetings and Coordinate/consolidate WO/CO with Procurement/ Finance and Provider- Support and train clinical users (Europe, Asia; Latina America) on IRS set up on clinical & GMA trials- Process & system continuous improvement by developping new standard functionalities

- Coordinate RFP IRT, WO/CO IRT with clinical team and IRT provider - Develop (Study Specifications & UATs), Implement and follow up IRT activities with the clinical team and Provider - Responsible for packaging & labelling, shipment, return and reconciliation with CTM, CLC, CSU and RA labeling

- Member of the Clinical Team, responsible for overall study preparation, conduct and close out- Train and Coordinate investigator sites, CRO and CRA’s , Strong interaction with others Departments- Responsible for Country faisability, CRO and sites identification / selection- Management of product and supplies, IRB and RA submission activities, eTMF, eCRF, CTMS and IRT- Therapeutic areas pandemic Influenza vaccine,CMV, superficial bladder cancer, HIV, Influenza transcutaneous route

- Review CDM documents, reconcile data & manage DCF flow from CDM and/or PV to investigator site- Define standards on CRF completion guidelines accross clinical trials and clinical project level