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PRA Health Sciences
- Clinical Team Manager
2013 - maintenant
Responsible for some Western and Eastern Europe countries on a global phase III hematology study.
Western Europe CTM Lead: responsible for coordination of a 4-CTM team managing all WEU countries.
Accountable for achieving successful delivery of clinical activities (site start-up and site monitoring) by meeting internal and external requirements according to time, quality and budget constraints.
Project leadership: Lead and direct cross-functional internal teams (CRAs, contract associates, in house-CRAs, regulatory specialists) and external vendors to manage client expectations and ensure clinical monitoring outcomes are achieved by maintaining a timely and effective communication (setting priorities and providing project objectives, expectations and status updates).
Project oversight: Supervise subject screening/enrollment, CRF retrieval and ensure internal project reporting systems are up to date; Proactive identification of issues and risks to clinical activities and development of contingency / mitigation plans; serve as primary liaison with client, vendors and internal functional department for clinical monitoring issues.
Project resourcing: Management of clinical monitoring resources throughout the study by participating in clinical resource request process and liaising with local clinical operation managers to resolve resource and performance issues.
Project finance: Forecast hours for start-up and monitoring activities and analyze forecasted and worked activities to ensure adherence with scope and budget; Identification and escalation of any out of scope activity.
Project quality: collaborate with QA department to identify sites needing corrective and preventative action plans, and escalation to client.
Project training: create and maintain clinical project documents and tools; conduct study specific training for the team (as needed and for new team members).
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PRA International
- CRA
2012 - 2013
Therapeutic areas: Haematology, Oncology, Central Nervous System
Sponsors: Roche, Celgene, Onyx Pharmaceuticals, UCB, Bayer HealthCare
Site selection and site initiation visits
site management (phone contact, visits scheduling)
monitoring visits (ICF, AE/SAE, SDV, ISF update, drug accountability, DCF resolution)
Active participation in CRA and investigators meetings
Mentoring of newly hired CRA
Audit finding resolution
Site close out visits
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Quintiles
- CRA
Durham
2010 - 2012
Therapeutic areas: Haematology, Oncology, Central Nervous System
Sponsors: Roche, Novartis, Genentech, Celgene, Medimmune, Schering Plough, Exelixis, Johnson&Johnson, Astellas
Site selection and site initiation visits
site management (phone contact, visits scheduling)
monitoring visits (ICF, AE/SAE, SDV, ISF update, drug accountability, DCF resolution)
Audit finding resolution
Site close out visits
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Gelarc
- ARC
2008 - 2010
Monitoring d'études internationales de phase I à III sur population de patients atteints de lymphome non hodgkinien. Toutes les activités de monitoring ont été réalisées, de la visite d'initiation (SIV) à la visite de cloture (SCOV)
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CNRS
- PhD student
Paris
2004 - 2008
Analyse moleculaire de l'intégration séquentielle des signaux métaboliques et circadiens dans le controle de la division cellulaire
