Mes compétences :
Industrie pharmaceutique
Qualité
Gestion de projet
Galénique
Entreprises
Covance
- Chef de Projet Senior
Princeton2018 - maintenant
Covance
- Chef de Projet Global
Princeton2016 - 2018
Covance
- CTL
Princeton2013 - 2016
Covance
- CRA /Lead CRA/EU PM
Princeton2005 - 2013From 24 October 2005 - Onwards
Lead CRA:
Lead responsibilities on several international projects. Working on line with monitors from Russia, Romania, Ukraine, Latvia, Germany .......
Review and validate reports, issue resolution and escalation , creation and approval of study documents, hosting T-cons, direct contacts with vendors for study requests, validate study budgets....
Senior CRA:
Experienced in monitoring phase II, III and IV protocols either in specialized medicine or with general practitioners, skills in multiple project monitoring. Knowledge of Good Clinical Practices (GCP) and ICH guidelines.
Key Responsibilities
Responsible for all aspects of study site monitoring (national and international) including:
- Perform feasibility studies and Sites selection for participation in study.
- Conduct of pre-study , initiation visits, routine monitoring and close-out of clinical sites
- Provide technical training to sites staff. (e-CRF- phase forward, ECG machine, spirometry equipment-MSCT).
- Maintenance of study files ( local and SFN)
- Prepare regulatory documents for submission under the French Law (ICF, Study summary, …)
- Ensure the study staffs who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Prepare accurate and timely trip reports.
- Handling AE and SAE reporting (tracking and follow-up of SAEs)
- Queries resolution and collection in timely manner
- Contacts with sponsors and liaise with vendors.
- Contact with several departments: financial, biometrics, safety, laboratory …. ( internal)
- Update, track, and maintain study-specific trial management tools/systems.
- Generate and track drug shipments and supplies as needed
- Attend investigators’ meetings, project team meetings and teleconference.
- Participate in site budget managing and investigator payment – Budget negotiation with investigators and hospital directions -overheads
- Submission of investigators fees to National Physicians Board
- Hire sites CRC for participation in studies
- Provide training and support to new CRA assigned to the studies
- Reviewing visits reports
ADDS
- CRA
2003 - 2005ADDS, Paris
Country Study Coordinator: Phase IV trial
- Key Responsibilities
1. • Managing a team of 6 CRAs
2. • Helping project manager in daily activities – supervisory of clinical trial assistant activities (study logistic, filing, archiving, , investigator payments, mailing to sites and mailing to Sponsor )
3. • Assist with project specific training to junior staff
4. • Coordination work between the PM and the CRAs and with sponsor and vendors.
5. • Handling AE reporting to the Sponsor.
6. • Participate in Data validation plan and create queries : perform CRF review, query generation and resolution against established data review guidelines, on company management systems
7. • Performing initiation, monitoring and audit visits
8. • Queries resolution and collection in timely manner
CRA, Phase II trial- Cardiology
- Key Responsibilities
1. Investigator e-CRF training
2. Conduct of pre-study and site initiation visits
Unblinded CRA, phase III trial-Dermatology
- Key Responsibilities
1. conduct of site initiation, monitoring & close-out visits
2. Drug accountability on-site according to ICH/GCP
3. Investigator/site file maintenance
4. Investigator e-CRF training.
CRA, phase IV trial-Neurology
1. conduct of monitoring & close-out visits
2. Drug accountability on-site according to ICH/GCP
3. Investigator/site file maintenance
CRA, phase III trial-Endocrinology
1. conduct of site initiation and monitoring & visits
2. Drug accountability on-site according to ICH/GCP
3. Investigator/site file maintenance
