1. Philippe MASSIOT, PhD
43 years old
10 bis rue Geoffroy Marie Tel: +33 (0)6 78 74 85 46
75009 Paris - France massiot.philippe@gmail.com
SKILLS
 Good knowledge in multi-site international clinical studies
 Team work, initiative, adaptability
 Participation in Business Development proposals
 Liaison with customers, CROs, experts, suppliers
 Milestones/Timelines keeper
 Management of the project budget
 Good knowledge of GCP/ICH guidelines
 Knowledge in Regulatory Affairs (6-month mission)
LANGUAGE SKILLS
 French, mother tongue
 English, fluent
 Spanish, fluent (3 years spent in Spain)
WORK EXPERIENCE
Clinical Project Coordinator
Clinical Development unit (oncology), PIERRE FABRE Laboratories (Boulogne)
Since March 2011
 Management of study activities (phase I and III) conducted in different countries
 Responsible for the accuracy of the data collected by the CRAs
 Validation of clinical data
 Collaboration in the amendments of the protocol and study related documents
 Regulatory and administrative management
 Follow up of budget
 Pre-selection, initiation and monitoring visits on site
 Investigational product management
 CRF, eCRF, IWRS design and specifications
 CRA training
 Trial Master File
 Project meetings (Investigator meeting, CRA meeting, …)
 Communication with subsidiaries, CROs, commercial partners
 EMA inspection
6-month mission (May to Dec. 2015) as a Project Manager in International Regulatory Affairs:
 Management of Labeling (Product Information) documents (CCDS, CorePIL,…)
 Improvement of the different processes related to the Reference Product Information
Project Manager
Centralized Medical Imaging Services, SYNARC Paris (Sèvres)
Jan 2008 - Jul. 2010
 Management of the set up, follow up and coordination of international clinical research projects
(phases II and III) in various therapeutics area (in particular in cardiovascular and oncology
therapeutics area)
PROJECT MANAGEMENT IN CLINICAL RESEARCH

2.  Cross-functional activities with Operations, Data Management and Business teams (with the
Synarc units based in Paris, San Francisco and Hamburg)
 Coordination and communication with the external participants to the project (sponsor, CROs,
investigator sites, experts, suppliers, …)
 Allocation of internal resources dedicated to the project
 Supervision of the execution of contracted services to fulfill to requirements from the sponsor
 Responsible for the deliverables (respect of milestones and timelines)
 Development of study specific documents in cooperation with medical/scientific team
 Participation in the external meetings related to the project (kick-off meetings, investigator
meetings, bid-defence meetings, follow-up meetings, …)
 Preparation and participation in audits
 Invoicing; budget driving
 Implementation of a global platform (normalization of work processes; unique database)
International Project Leader
Centralized Cardiac Services, MDS Pharma Services (Baillet)
Nov. 2003 - Jan. 2008
 Management of the centralization of cardiac services of overall international clinical study (phase I
to IV), from the set-up to closure
 Main contact for the Client (pharmaceutical companies)
 Management of cross-functional activities with Operations, Data Management and Business
teams (with the MDS units based in Paris, Toronto and Singapore)
 Responsible for the validation of clinical software database
 Logistical coordination (cardiac devices)
 Responsible for study team training by conducting regular team meetings and communication
sessions and provide coaching to other members of the team
 Participation and presentations at investigator, monitor and client meetings
 Creation and supervision of study specific documents
 Responsible for ensuring that design, implementation and timelines of study deliverables are
consistent with client and budget expectations
 Coordination and communication with the various external participants to the project (sponsor,
CROs, investigator sites, cardiologists, suppliers, …)
 Allocation of internal resources dedicated to the project
 Participation in the implementation of a global platform (unique database)
International Project Coordinator
Central Laboratory, MDS Pharma Services (Baillet)
Apr. 2002 - Nov. 2003
 Responsible for supporting Project Leader in the centralization of biological analysis for
international clinical study management (Phase I to IV)
 Responsible for all site management activities (site initiation; logistical coordination,..)
 Main contact for investigators and CRAs
 Coordination of activities related to investigator sites; monitoring of site queries
 Understanding of the study budget with respect to their other study activities
Scientific Researcher in Chemistry
CSIC, Institute of the Science of Materials of Sevilla, Sevilla, España
Instituto de Ciencia de Materiales de Sevilla CSIC-ICMSE (Spain)
March 1999 - Apr. 2002
 Design and development of a synthesis line (sol-gel)
 Training and coaching of students and technicians
 Writing of scientific articles

3. EDUCATION
1995 – 1998 PhD (Inorganic Chemistry), University of Rennes (France)
1994 – 1995 Master Science of Inorganic Chemistry, University of Rennes (France)