Martine Gestin Email & Phone Number

Région De Rennes, France

Therapeutic area : oncology, phases II to IV. Interventionnal studies : drugs, medical devices.Budget planning and monitoring.CRO selection.Documentation preparation (protocol, informed consent, EudraCT, CPP and French agency packages) for regulatory submissions.Direct line manager of CRAs and Data Manager : training, performance assessment and development.Ensure delivery of all elements of study execution : sites set-up, data recording, deadlines respect, safety reporting, close-out and final report.

Responsible for the study management at a country level under guidance of a Director to: Lead the Country Operation Leads (COL) to secure the project management in line with Pfizer strategies  Ensure overall quality and compliance  Ensure appropriate oversight of monitoring supported by the COL Coach, develop and direct performance of the COL to achieve business goals and optimize overall effectiveness Ensure site issues management in timely manner Develop and maintain constructive relationships with the assigned BU team to facilitate teamwork, communication, strategic alignment and development of business opportunities that enhance the conduct of clinical trials Contribute to the elaboration and implementation of strategic direction and initiatives of the country leadership team Ensure efficient planning and prioritization in liaison with the Clinical Project Management Develop and execute individual development plan to enhance performance of country enrollment targets Coordinate local resources, such as COLs as necessary to support execution of protocols Demonstrate leadership to support the COL to maintain sound Investigator relations

- Ensure delivery of all Pfizer elements of study execution in clinical trials assigned to a preferred CRO (Quintiles)- Ensure appropriate oversight of all Pfizer required elements in clinical trials assigned to CROs in fully outsourced studies.- Coordinate Pfizer internal resources within other platform lines (legal, Contract, supplies, regulatory, safety) in support of studies to ensure all team and operations goals are met- Serves as primary point of contact for the CROs for all start up activities, facilitate interactions between the CRO and Pfizer at a local level.- Provide oversight of CROs to ensure Pfizer obligations as Sponsor are being met.

In charge clinical trials development of North-West from feasibilities to closeout, every therapeutic areas with a focus for oncology. Direct line manager of CRAs: training, performance assessment and development.

Supervision et management d'une équipe régionale d'ARCs : . en charge du recrutement et de la formation, attribution des études et évaluation de la charge de travail. garant du respect des deadlines, de la qualité du travailsur site, de la qualité des rapports de monitoring. responsable de l'établissement du plan individuel de développement. organisation et présentation de réunions régionales transversales- Supervision de l'activité d'ARCs régionaux prestataires :. allocation des études en partenariat avec le line manager,. covisites notamment les pretrials afin de confirmer la sélectiondes centres- Mise en oeuvre d'un plan de développement régional :. identification des priorités de développement de la région, création de listes de centres privilégiés, réalisation des faisabilités toutes gammes thérapeutiques - Identification et mise en place de formations destinées aux investigateurs, personnels hospitaliers - Mise en place de partenariats avec les CRCs

- Coordination et supervision française d'essais cliniques internationaux de phases II et III- Responsable du planning, du budget, des soumissions réglementaires- Reporting direct avec le study team et les Attachés de Recherche Clinique régionalisés- Responsable du respect des procédures et de l'éthique

- Coordination française d'essais cliniques internationaux : faisabilités, sélection des centres d'investigation, responsable du budget, des mises en place administrative et logistique, monitoring des centres de l'initiation à la fermeture.- Phases II et III : aspergillose invasive, urologie, réanimation pédiatrique, cardiologie

- En mission chez Pfizer- Mêmes responsabilités que celles exercées de 2001 à 2003- Phases III : aspergillose invasive

- Activités de monitoring- Phases II et III : cancer du sein métastatique, asthme, sclérose latérale amyotrophique - Trois clients

Doctorat, Biologie

Dea, Biologie Cellulaire, Moléculaire Et Sciences De La Santé