- Lead PM for IRT (Interactive Response Technology) management on phases III / IV clinical studies - Main point of contact for the client during study maintenance - Interface between sponsor representatives and company- Provide regular updates to client on study related information- Provide expertise on drug supply and patient management- Proactively review drug supply strategy and study data for improvements and identify risks- Organize or participate in regular client meetings (CTT)- Coordination and management of internal and outsourced resources (technical team, helpdesk/support, finance, translations agencies).- Coordinate the implementation and review of the data changes and system change requests- Review Helpdesk tickets, investigate and take appropriate actions to resolve the issues - Write study user guides and conduct training at investigator/monitor meetings- Manage budget and Change Orders (COs) as required- Attend client audits and bid defences

PM Team Lead (4 Project Managers) - Lead PM for eCOA (Electronic Clinical Outcomes Assessments) implementation and management on phases III / IV clinical studies (ePRO/eCRF/eDiary/eClinRO) and on Central Monitoring projects (eICF)- Main contact for the Client - Interface between the Client and the company- Participate to Client meetings- Provide expertise on eCOA implementation - Assist the sales team in the pre-sale phase and in bid defenses- Manage issue resolution plan and follow up with internal teams and ensure good communication with the Client- Involved in product and system upgrades and roadmap management- Responsible for internal processes review and improvement- Responsible for the overall study delivery, from drafting of the specifications to the final delivery of the project based on customer requirements- Responsible for ensuring all operational trial deliverables are met according to client specifications, timelines, budget, and procedures and quality standards- Coordination and management of internal and outsourced resources - Responsible for Sponsor / Monitors / Investigators trainings (training / guideline materials and Investigators Meetings participation)- Responsible from mentoring and training of internal resources- Prepare and support Client audits

Lead Project Manager (PM) for eCOA implementation on multiple phases I to IV studies (ePRO/eCRF/eDiary/eClinRO) and on Central Monitoring projects (eICF):- Responsible for the overall study delivery, from drafting of the specifications to the final delivery of the project based on customer requirements.- Responsible for ensuring all operational trial deliverables are met according to client specifications, timelines, budget, and procedures and quality standards.- Main contact for sponsor: Trial Leader, Clinical Study Manager, CRAs and Vendor Logistic Manager (F2F / TC meetings, CTT meeting participation, on regular basis reports and trackers)- Responsible for sites initialization, follow-up and management- Coordination and management of internal resources (Data Management,Technical teams, Logistic, Support, Finance)- Coordination and management of outsourced resources (design and printing of forms, setup and delivery of the digital pens / tablets, helpdesk and site assistance) - Data management team coordination and management (data management documents production (DCP, DMP), weekly report drafting, customers tracker management, planning management, SQL request)- Follow up issue resolution plan with internal teams and ensure good communication with sponsor- Responsible for the sponsor / CRA / sites training (training and guideline materials and IM participation)- Review Helpdesk tickets that get escalated to PM and take appropriate actions to resolve them as quickly as possible- Quality control of the whole course of setup and delivery

- Drug dispensation and management- Clients advices- Quality Controls- Staff management

- Procedure, Work instruction, and Forms redaction, update and implementation- Quality management expertise- Staff training (PWP presentation, evaluation, on the job formation) - New processes implementation follow-up- Unblinded Clinical research pharmacist

Phase I Clinical Studies management (SAD/MAD, DDI, TQT, Food effect, Relative Bioavailability, PD):- Study development and coordination: Protocol development, Instruction & management of Clinical Staff, investigator meeting - On site IMPs management: Importation, Storage, Accountability, Destruction- GMP-activities: Labelling, Packaging, Certificate of Packaging, Quality control of IMPs, On site pharmaceutical material/premises management- Regulatory activities: Communication with EC (EC submission, beginning/end of trial declaration…), CTA preparation, Importation Licence, Insurance request- Procedures redaction and implementation: All pharmaceutical process map and pharma-related SOPs of ITEM-ROCHE updated between April 2010 and December 2010)

Phase I Clinical Studies management (DDI):- Protocol design and redaction- Study conduct and follow-up: On-Site visits and site visits reports (Initiation and Qc visit), CRAs management, data cleaning, queries writing - Project management (Study coordination, Planning, Interface between science and operation)- Scientific interface with the study sites (CRO, safety, Analytic laboratories, Statisticians, Data managers)- Documents reviewing and writing (Protocol, Final Study Report, CRF, ICF, IB, CTA)- Statistical analysis (Statistical Analytical Plan development, PK/PD data analysis) - Safety evaluation (SAE and AEs review, SAEs management, safety reports)