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PRA international
- Senior Project Manager
2012 - maintenant
• Neurology, Parkinson disease, 2 Phase IV studies, global studies
All aspects of project management
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PRA International
- Project Manager
2011 - 2012
• Neurology, Epilepsy, Phase III global study and long term follow-up study, global studies
• Haematology / Oncology, acute graft versus host disease, global study
• Allergy, Peanut allergy, Phase IIb / III global study
• Cardiology, Unstable Angina, Phase II, international study
• Neurology, Epilepsy, observational international study
• Cardiology, Acute Venous Thromboembolism, phase III globall study
All aspects of project management
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Chiltern International
- Project Manager
Slough
2008 - 2011
• Urology, Overactive bladder, Phase II, global study
• Metabolic disorders, chronic hyponatremia, phase III global study
• Haematology, acute graft versus host disease, phase III international study
• Urology, idiopathic overactive bladder, phase II international study
• Rheumatology, rheumatoid arthritis, phase IIIb international study
- All aspects of project management, including being key communication link for sponsor company, study team and liaison with in-house departments (medical writing, medical monitor, regulatory, clinical monitoring, start-up team, pharmacovigilance, programming, data management, statistics, records management, contract and legal, finances, quality assurance), participation in bid defence meetings, kick-off meetings, presentation in CRA trainings, chairing the teleconferences and meetings (including blind review meeting), third parties vendors management (central lab, drug supplies, IVRS, ePRO vendor, translation company, printer) and ensuring adherence to time, budget and quality, study plans writing, progress monitoring and reporting. Participation in audits and MHRA inspection.
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Chiltern International
- Lead CRA
Slough
2005 - 2008
• Neurology, spasticity in multiple sclerosis, phase II, international study
• Urology, idiopathic overactive bladder, phase II international study
• Haematology, acute graft versus host disease, phase II international study
• Pain, central neuropathic pain in multiple sclerosis, phase III international study
• Pneumology, cystic fibrosis, phase III international study
• Oncology, metastatic renal cell adenocarinoma, observational, national, mono-centre study
• Pain, cyclical mastalgia, phase III global study
- Coordination of CRAs, mentoring of jr CRAs, MW, regulatory, PV, QA, DM and stat dep. coordination, management of vendors
- Attendance to kick-off meetings, presentation at CRA trainings and inv meetings
- Chairing of teleconferences, monthly face to face meetings with sponsor and cross-functional meetings
- Study documents, guidelines and tracking table creation
- Coordination of EC, reg. submissions and local contracts negociation
- Coordination of sites identification, feasibility assessments, pre-study, initiation, monitoring and termination visits ; co-visits ; review and sign-off of reports ; coordination and attendance to audit visits and corrective actions follow-up management
- Coordination of project finances with PM
- Coordination of set-up and maintenance of TMF
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Chiltern International
- CRA
Slough
2003 - 2006
• Immunology, primary immunodeficiency, phase III international study
• Paediatrics, recurrent ENT infections, phase IV national study
- Site feasibility, pre-study, initiation, monitoring and termination visits
- Mentoring of junior CRAs
- Study documents creations and review, QC of translations
- EC and import licencesapplications
- Liaison with sponsor companies and with regulatory, DM and PV dep.
- Attendance to European initiation meetings
- Sites administrative and financial follow-up, set-up of the financial agreements
- Set-up and maintenance of local TMF
- Preparation of sites to audits and corrective actions report follow-up
