Paris
* Compliance and Oversight Lead since Oct12 at Hays Pharma on assignmenet for Pfizer:
- Local Oversight of CRO monitoring quality according to Sponsor procedures.
- Conducts ongoing Protocol Specific Quality Review Visits (PSQRVs) with CRAs from CRO to ensure compliance with ICH/GCP, adherence to protocol/SOPs, ensure resolution of site issues and oversees escalation efforts, continued quality performance and effectiveness of monitors and investigator sites.
- Ensure that the CRAs assigned to the studies are qualified and trained to Sponsor procedures.
- Review the CRA monitoring visit reports.
- Follow the CRO performance and ensure CRO put in place appropriate actions.
- Audit preparation.
- Identify and manage risks across the countries and protocol.
- Follow-up and communications through resolution on all PSQRV findings.
- Therapeutic areas: rheumatology, dermatology, kidney transplant studies. International clinical trials in phase II and III.
* Senior CRA from Aug 2006 to Sep 2012 at PPD France:
- Therapeutic experience: phases II and III in infectiology (HIV), oncology, cardiology, thrombosis studies.
- Coordinating tasks: Assists the CTM with the study documents design (CRF guidelines, Monitoring Plan), Review the CRA monitoring reports, Participates in completion of study related documents (ICF, source template document, training manuals), Involves in coaching and training less experienced CRAs and conducting accompanied field visits on site and co-monitoring, Involves in Ethics Committee submission activities (Amendments, notifications and approvals) for 6 Oncology and 1 kidney transplant studies.
- Participates in the on-boarding and training of new staff.
- Involves in tools improvement, processes (CTMS) and procedures.
- Performs and coordinates assigned aspects of the clinical monitoring process.
- Develops collaborative relationships with investigational sites.
- Conducted Evaluation, Initiation, Monitoring, co-monitoring, and Close-out visits at investigative sites in France and Switzerland.
- Coordination activities within Feasibilities, Selections and Databases lock.
- CRF Collection, follow-up and data queries resolution, study progress reporting to Clinical Trial Manager
and/or Sponsor.
- Management of study drug accountability and SAEs.
- Contracts, fees and overcasts management.
- Experienced with paper CRF, eCRF systems and CTMS.
- TMF management (returns, filing and tracking).
Education:
Supsanté 2005 to 2006 Clinical Trial Management degree,
Université Pierre et Marie Curie (Paris VI)2004 to 2005 Specialised post-graduate degree “Research and Development in Biotechnologies”,
Université Paris Val de Marne (Paris XII) 2003 to 2004 Master degree, Cellular Biology and Physiology.
Competencies:
- Ability to manage simultaneously several projects with different Therapeutic Areas, different timelines, different contact.
- Experienced with clinical operation procedures,
- Experienced with eCRF systems, CTMS
- Communications Skills.
- Dynamic, Organized.
-Languages:
French,
English (professionnal)
-Additional Trainings: Management of Stress, Improvement on communication Skills.
Mes compétences :
dynamic
Organized
Proactive
