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Recherche-Etudes Cliniques

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Project Manager / Coordinator
Catégorie :

Recherche-Etudes Cliniques

Date de dernière mise à jour :

9 juillet 2011

Lieu :

Paris / Madrid

CV :

Currently:
Clinical Project Coordinator
Institut de Recherche PIERRE FABRE (Boulogne-Billancourt)
Clinical Development - Oncology

- Responsible for the accuracy of the data collected by the CRAs
- Collaboration in the amendments of the protocol and study related documents
- Cooperation with the Biometry department
- Requests to the Clinical Pharmacy ; coordination of the shipments during the study
- Participation in the CRA training
- Follow up of budget
- Validation of clinical data
- Participation in project meetings (Investigator meeting, CRA meeting, …)


Jan. 2008 – Jul. 2010
Project Manager
Synarc Paris, Sèvres (92 - France)
Centralized Medical Imaging

- Responsible for 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 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
- Participation in the implementation of a global platform (normalization of work processes; unique database)

Nov. 2003 – Jan. 2008
International Project Leader
MDS Pharma Services (Clearstone Laboratories since 2010), Baillet (95 - France)
Centralized Cardiac Services

- Responsible for the centralization of cardiac services of overall international clinical study management (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)


Apr. 2002 – Nov. 2003
International Project Coordinator
MDS Pharma Services (Clearstone Laboratories since 2010), Baillet (95 - France)
Central Laboratory

- 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


March 1999 – Apr. 2002
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)

- Design and development of a synthesis line (sol-gel)
- Training and coaching of students and technicians
- Writing of scientific articles

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