1.
Philippe MASSIOT
PROJECT MANAGEMENT IN CLINICAL RESEARCH
SKILLS
Info PROJECT MANAGEMENT
43 years old
Contact
 +33 (0)6 78 74 85 46
 massiot.philippe
@gmail.com
 50 rue Cesbron
75017 Paris, France
 c/ Puerto Rico 37
46006 Valencia, Spain
 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 assignment)
LANGUAGES
 French, mother tongue
 English, fluent
 Spanish, fluent (3 years spent in Spain)
PROFESSIONAL EXPERIENCES
CLINICAL PROJECT COORDINATOR
PIERRE FABRE (Boulogne ‐ France)  Clinical Development Unit (Oncology)  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 management
 Project meetings (Investigator meeting, CRA meeting, …)
 Communication with subsidiaries, CROs, commercial partners
 EMA inspection
 6‐month assignment (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
SYNARC (Sèvres ‐ France)  Centralized Medical Imaging Services  Jan. 2008 to 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)
 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 fulfil requirements from the sponsor
 Responsible for the deliverables (respect of milestones and timelines)
 Development of study specific documents in cooperation with medical/scientific team

2.  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 supervision
 Implementation of a global platform (normalization of work processes; single database)
INTERNATIONAL PROJECT LEADER
MDS Pharma Services (Baillet ‐ France)  Centralized Cardiac Services  Nov. 2003 to 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 (single database)
INTERNATIONAL PROJECT COORDINATOR
MDS Pharma Services (Baillet ‐ France)  Central Laboratory  Apr. 2002 to 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‐ICMSE, Institute of the Science of Materials of Sevilla / Instituto de Ciencia de Materiales de
Sevilla (Sevilla ‐ Spain)  March 1999 to Apr. 2002
 Design and development of a synthesis line (sol‐gel)
 Training and coaching of students and technicians
 Writing of scientific articles
EDUCATION
Class about anti‐tumour chemotherapy and medical treatment for cancer
Institute Gustave‐Roussy (France)  January 2013
PhD (Inorganic Chemistry)
University of Rennes (France)  1995 to 1998
Master Science of Inorganic Chemistry
University of Rennes (France)  1994 to 1995
HOBBIES
Table tennis (Treasurer of the association)
Badminton
Theater