-
AB Science
- CRA Manager
2015 - maintenant
Responsible of line management of 7 CRA trainees and 3 CRAs, Quality Control of study database on key projects, and enhancement/update on company's standard operating procedures
Human resources management
* Conduction of weekly face-to-face meeting with CRAs to follow-up on employee's procedures and perform coaching as needed. ;
* Integration and training of CRA trainees and assignement of trainees to projects and support requests as needed. ;
* Job interviews of candidates to positions of CRAs within the company ;
* Completion of regular training sessions and public presentations in CRA meetings ;
* Evaluation of study needs and CRA workload and assignement of human resources as per project needs and available staff. ;
* Accompanied on-site visits to evaluate CRA performance on site and complete CRA trainees and CRA's coaching as per identified training needs. ;
* Back-up of clinical operations director during leaving.
Quality control management
* Redaction of internal documents and procedures for implementation within clinical research department (including monitoring guidelines, visit reports, templates of essential documents)
* Trend analysis and quality control of study database in key company's clinical trials for incoming submissions to competent authorities
* Evaluation of outstanding monitoring backlog and report to project managers for project performance's follow-up.
* Leadership in preparation of submission of study documents and database for review and approval by international competente authorities (FDA) of human and veterinarian studies.
* ;
-
Ppd
- Attaché de recherche clinique senior
2012 - maintenant
Je suis actuellement en charge de quatre essais cliniques de phase III, dont trois en maladies infectieuses (infections compliquées urinaires et intra-abdominales) et une en dermatologie (sclérodermie). J'ai été en charge des fonctions suivantes:
- Pré-sélection, initiation, suivi/monitoring et clôture de centres hospitaliers dans le cadre d'essais cliniques
- Soumissions des contrats et conventions financières au CNOM
- Soumissions de dossiers réglementaires aux comités d'éthiques et autorités de santé
- Comptabilité/suivi des paiements pour remboursement des trajets patients, rémunération des médecins et des centres hospitaliers
- Suivi de la négociation des contrats/conventions financières avec les médecins et institutions jusqu'à signature
- Préparation de centre hospitalier pour une visite d'audit
- Formation/coaching d'un ARC junior dans le cadre d'un essai clinique
-
PPD International
- Senior clinical research associate
2012 - 2015
Involved in 8 clinical trials on: complicated urinary and intra-abdominal infections (3 phase III projects), scleroderma (Phase III), Fabry disease (Phase III), prostate cancer (2 phase III projects), glaucoma (Phase II)
Project management
* Defined scope of the clinical trial protocol and its feasibility in pre-selected sites
* Replaced project manager during his leaving to handle project management tasks
* Defined sites' local strategy for study conduct, patients' recruitment and management with site staff members.
* Trained teams in hospitals including head of medical departments, lab managers, doctors, nurses, pharmacists
* Engaged and scheduled audit visits in France and abroad resulted in 2 onsite visits per week.
* Prepared sites involved in a clinical trial to one audit visit performed by client's Quality Assurance and implemented corrective and preventive actions till resolution and confirmation of client's satisfaction.
* Managed study budget for reimbursement of study-related fees to patients.
* Managed study's accountability for payment of claimed investigator and hospital direction fees.
* Analyzed certification of local lab departments and supplies used on site (temperature controller devices, fridges, freezers, centrifuges)
* Monitored sites located in France, Switzerland and England
*
Strategic analysis
* Provided suggested list of sites and physicians for conduct of one major clincial trial. the client validated CRA's suggestions.
* Implemented customed solutions on site to solve organizational or logistical issues on sites for clinical trial conduct after validation by the client.
* Worked within internal local team to create new procedures and strategical approach to enhance patients' recruitment rate in sites enrolled in clinical trials.
*
Communication / Negotiation skills
* Engaged relationships with medical staff to promote medical research and ensure clinical trial follow-up in France.
* Provided complete reports and status of clinical trials on site to the clients who are multinational lab companies
* Negotiated financial agreements with investigators (physicians), physicians' associations and institutions (hospital directions, pharmacy department, local labs)
* Mentored and managed junior staff and support them in their development
* Participated within internal working group to the creation of new supportive documents and procedures to enhance communication with sites and patients' recruitment in clinical trials.
* Redacted local newsletters about office's processes' evolution ;
-
Covance
- Senior clinical research associate
Princeton
2011 - 2012
Involved in 2 clinical trials on: hypercholesterolemia (phase III), diabetic retinopathy (phase II)
Project management
* Defined sites' local strategy for study conduct, patients' recruitment and management with site staff members.
* Trained teams in hospitals including head of medical departments, lab managers, doctors, nurses, pharmacists
* Engaged and scheduled audit visits in France and abroad resulted in 3 onsite visits per week.
* Prepared sites involved in a clinical trial to two audit visit performed by client's Quality Assurance and implemented corrective and preventive actions till resolution and confirmation of client's satisfaction.
* Managed study budget for reimbursement of study-related fees to patients.
* Managed study's accountability for payment of claimed investigator and hospital direction fees.
* Analyzed certification of local lab departments and supplies used on site (temperature controller devices, fridges, freezers, centrifuges)
Communication / Negotiation skills
Engaged relationships with medical staff to promote medical research and ensure clinical trial follow-up in France.
* Provided complete reports and status of clinical trials on site to the clients who are multinational lab companies
* Negotiated financial agreements with investigators (physicians), physicians' associations and institutions (hospital directions)
* Mentored a junior clinical research associate for training to job requirements and involvement in clinical trials. One of the two clinical trials was successfully handed over to the junior CRA at the time of the leaving of the company. ;
-
Covance Clinical
- Attaché de recherche clinique Senior.
2011 - 2012
Je suis en charge de deux essais cliniques dont:
- Un essai de phase III sur l'hypercholestérolémie primaire et la dyslipidémie mixte
- Un essai de phase II sur la rétinopathie diabétique
Je suis en charge des activités suivantes:
- Initiation et monitoring de centres Français
- Suivi des négociations de contrats investigateurs, associations et institutions jusqu'à signature.
- Suivi du remboursement de trajets patients
- Suivi de certifications de centres pour l'envoi de données en laboratoire d'imagerie centralisée.
- Préparation de centres à des visites d'audit et suivi des requêtes d'audit jusqu'à résolution (deux audits conduits à ce jour)
-
ICON Clinical research
- Attaché de recherche clinique Senior.
2007 - 2011
Recruté en tant qu'attaché de recherche clinique en Juin 2007, j'ai été promu attaché de recherche clinique niveau 2 en Juin 2008 puis attaché de recherche clinique senior en Juillet 2010.
J'ai été en charge de six essais cliniques dont:
- Une étude de phase III sur le syndrôme myélodysplasique
- Deux études cliniques de phase III sur la leucémie lymphoïde chronique.
- Une étude de phase II sur la thrombose veineuse chez des patients traités par chimiothérapie
_ Une étude observationnelle sur les acouphènes
- Une étude de phase II sur les acouphènes
- Une étude de phase II sur l'hépatocarcinome.
J'ai été en charge des tâches suivantes:
- Initiation, monitoring (y compris département pharmacie) et clôture de centres basés en France et en Belgique.
_ Préparation de documents et soumission aux comités d'éthique, autorités de santé (AFFSAPS, CNOM, CNIL, CCTIRS, ministère de la santé Belge)
- Négociation et suivi jusqu'à signature de contrats investigateurs, institutions, pharmacie, département radiologie.
_ Suivi des paiements investigateurs et paiements des trajets patients.
- Revue de rapports de monitoring et de bases de données dans le cadre de contrôles qualité
- Préparation et suivi de visites d'audit pour deux des essais cliniques (complétés avec succès).
-
ICON Clinical Research
- Clinical research associate
2007 - 2011
Involved in x clinical trials on; myelodysplastic syndrome (phase III), chronic lymphocytic leukemia (phase III), veinous thrombosis (phase II), tinnitus syndrome (observational study), liver cancer (phase II)
-
Quintiles S.A.
- Clinical research associate
2006 - 2007
Hired for outsourced mission in client's organization (AstraZeneca, Rueil-Malmaison)
Involved in 4 clinical trials on; prostate cancer (phase II), breast cancer (phase III and phase IV), non-small cell lung cancer (phase III)
Project management
* Defined sites' local strategy for study conduct, patients' recruitment and management with site staff members.
* Trained teams in hospitals including head of medical departments, lab managers, doctors, nurses, pharmacists
* Engaged and scheduled audit visits in France and abroad resulted in 4 onsite visits per week. ;
-
Quintiles S.A.
- Attaché de recherche clinique
2006 - 2007
J'ai travaillé pour le compte de "Quintiles S.A." au sein du laboratoire AstraZeneca en tant qu'attaché de recherche clinique.
J'ai été impliqué dans 4 études cliniques, dont une de phase II sur le cancer de la prostate, deux de phase III et IV sur le cancer du sein, une de phase III sur le cancer du poumon non à petites cellules.
j'ai été en charge de l'initiation, du monitoring (y compris suivi du département pharmacie) et de la clôture de centres Français.
-
Cvitkovic & Associates Consulting
- Junior clinical research associate
2005 - 2006
Involved in 3 clinical trials on; prostate cancer (phase III), breast cancer (phase III), colorectal cancer (phase III)
Project management
* Defined sites' local strategy for study conduct, patients' recruitment and management with site staff members.
* Trained teams in hospitals including head of medical departments, lab managers, doctors, nurses, pharmacists
* Performed regular onsite visits for follow-up of study conduct.
* Engaged and scheduled audit visits in France and Italy and abroad resulted in 2 onsite visits/week. ;
-
Cvitkovik & Associés Consultants
- Attaché de recherche clinique
2005 - 2006
J'ai participé à un essai clinique de phase III sur les métastases cérébrales du cancer du sein.
J'ai été en charge de 9 centres basés en Italie.
J'ai effectué des initiations, du monitoring, du suivi des départements pharmacie, des préparations de documents et soumissions aux comités d'Ethique et Autorités de Santé.
J'ai été impliqué dans la négociation et la finalisation de contrats investigateurs, associations, institutions et avec les départements radiologie.
Pour le compte d'une autre étude de phase III sur le cancer colorectal, j'ai effectué une revue de bases de données et de profils patients, de l'encodage de données et de l'édition de "queries".
- Préparation de centres à des visites d'audit et suivi des rapports d'audit jusqu'à résolution (2 visites effectuées)
