Philippe Moreau Email and Phone Number

Manages, selects, trains, coaches and performance management of Clinical Managers and operations teams in France. Accountable for functional management of Clinical Managers to ensure successful execution of all clinical deliverables within assigned projects with focus on quality deliverables and Risk Management. May represent Clinical Management in global and/or cross-functional initiatives.Oversees the Recruitment for the Regional Operation Delivery in France (Start-up and Maintenance roles, Clinical Managers). Oversees the quality activities for the department (audit/inspection preparation, training, CRA induction, training and performance visits.

Responsible for the line management, recruitment and selection, training, coaching, professional development and performance of designated Clinical Management staff (CRAs, RSMs).Work with other department to achieve target and ensure delivery and metrics are aligned with time, quality, financial expectations.Participation in transversal initiatives, referent Manager for CRA recruitment, CTMS-Dashboard systems, Quality Plan, Freelance related activities, Induction visits for CRA

** Head of the Monitoring Resources Unit - Europe; part of Clinical Operations Department** Responsible for the development, maintenance, selection, contracting and follow-up of the European network of contracted CRAs ** Responsible for the management and coordination of resources of internal Monitoring staffs: Clinical Research Associates, Site Management Associates (responsible for the remote management of investigational sites in Europe).** Participation in qualification audit of regional CROs as operational expert

** Management of Internal Clinical Research Associates, Site Management Associates (responsible for the remote management of investigational sites in Europe, organised in phoning room)** Operational contact of contracted CRAs in Europe** Evaluate plan, manage and coordinate resource assignment based on project specifications and resources, experience and expertise.** Liaise with internal departments to ensure selection, qualification, appropriate allocation and optimal utilization of associates. May be involved in candidate interview and screening. ** Responsible for integration, training, mentoring and coordination of associates.** Provide leadership and expertise for associates team to ensure successful project design, planning, implementation and delivery of quality services within established budget and timelines. ** Support development of departmental and project-specific processes including quality control measures to gain efficiencies and ensure quality across projects ** Participate in departmental project, validation exercises, and process improvement initiative.** Provide input to operational department to implement new or corrective programs, processes, support of monitoring strategies, communication with peers to ensure global consistencies in tools and expectations. ** Participate in the improvement of the Quality Assurance System** Participate in Business Development activities.

Previously Kendle international, acquired by INC Research in July 2011** Responsible for coordinating the performance and line management of Clinical Operations staff (20-25) including office-based and home-based (regional), Lead Clinical Research Associates (Lead CRAs), Clinical Research Associates (CRAs), In-house Clinical Research Associate (i-CRA) and Project Assistants (PA).** Monitor and evaluate associates workload and liaise with Resource Management and the Project Manager, to ensure appropriate allocation of resource and optimal utilization.** Initiate regular communication, one to one meetings and assign appropriate mentors with all allocated associates (according to set goals) and coordinate their performance reviews and appraisals including obtaining feedback from PMs and other Clinical Operations personnel where relevant. ** Identify and ensure all necessary training is provided to associates on an ongoing basis to optimise job performance and knowledge with particular emphasis on all relevant Company procedures, ICH-GCP and other local regulations.** Assist with continuous review of current processes and implementation of process improvements and participate in business development activities.

Outsourced Project Manager to a Pharmaceutical Vaccines Company from mid-July-07 to 31-Dec-08** To provide expertise and to design, conduct and evaluate clinical studies with excellent quality standards, so that the exploitation of the results in optimized for best product support.** Responsible for the overall direction, coordination, implementation, execution, control and completion of specific projects ensuring consistency with company strategy, commitments and goals.The role of the Project Manager is to plan, execute, and finalize projects according to strict deadlines and within budget. This includes acquiring resources and coordinatingthe efforts of team members and third-party contractors or consultants in order to deliver projects according to plan. The Project Manager will also define the project’s objectives and oversee quality control throughout its life cycle.** Line management of a group of 9 CRAs/Project Assistants.

Acquired by Kendle International Inc. August 16, 2006To provide functional leadership to a defined group of Clinical Monitoring staff working on a designated project (the Clinical Monitoring project team) to ensure satisfactory performance and completion of the project.

Acquired by Charles River Laboratories International Inc. October 20, 2004** Verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. ** Make sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement.** Review study documentations & proceed with regulatory submissions as per local requirements** Provide expert advice, guidance and general supervision to Clinical Monitoring team activities

please see above Job description for detailsThere are various levels at which a CRA can work: CRAI, CRAII & sCRA. These differing levels determine the tasks and responsibilities to be carried out, and are often experience dependent.

Acquired by Inveresk Research Group Ltd.April 3, 2001please see above Job description for detailsThere are various levels at which a CRA can work: CRAI, CRAII & sCRA. These differing levels determine the tasks and responsibilities to be carried out, and are often experience dependent

Clinical Research Associate in the genetics’ collection department, Lariboisiere Hospital & Robert Debre Hospital (Paris)- Clinical monitoring: monitor’s responsibilities, monitoring procedures, monitoring report- Data management: data base management- Study coordinator: subjects recruitment, blood sample managementand inventory control, analysis management, first statistic’sreconciliation.