freelance Chef de projet Chef de projet, Tunisia

Amira A. Senior CRA/Project Manager

  • France
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Chef de projet freelance Tunisia (7050)

Senior Cra/project Manager

I have an extensive experience in the management of clinical studies that I gained through the implementation and monitoring of different types of studies (Phase II, phase III , observational trials and Real world evidence). My primary objective was to ensure quality and reliability of collected data in compliance with regulations and good clinical practices according to timelines. I had worked in accordance with SOPs. During my course, I have ensured the realization of the study according to local regulations and protocol requirements. I have participated in site audit and e TMF audit performed by an ex FDA inspector with no major or critical findings. In addition I have participated in the implementation of a paediatric Trial in Tunisia and I have succeeded to obtain an exemption from MOH in order to start this trial. Furthermore, Please note that I am trained on implementation of clinical Trial from A to Z as I have been involved in all steps of trial conduct.

Compétences :

gestion de projet suivi BPC reglementation qualité monitoring audit

Expérience professionnelle


From Jan 2018 until now
Senior CRA, Project Manager MENA region, Real World Evidence (RWE) department Within IQVIA
The following tasks were handled for the below different Trials:
o Contact with study site team
o Single point of contact with different Sponsors.
o Travelling to meet Clients and different KOLs in MENA Region
o Collect regulatory and administrative documents needed for the constitution of
the regulatory file
o Manage relationships with sites.
o Keep and file any exchanged letters or e-mail with investigator
o Contract and Budget negotiation
o Preparing for Proposal in BID defense
o Participating in BID defense meeting
o Preparing and Arranging for Investigator meeting
o Accompanying CRA for onsite visit within Middle east North Africa (MENA)
region.
o Supervise the Quality of delivered work (review IMVR, RM…) within Real world
evidence projects within MENA region
The above is applicable for the following Trials:
- Regional Registry (Triple Negative Breast Cancer), in 12 countries ( Morocco, Algeria,
Tunisia, Egypt, Lebanon, UAE, Qatar, Kuwait, Oman, Jordan, Saudi Arabia, Iraq)
managing 23 sites
- PASS study (Diabetes Study) in 10 sites, 1 Country ( Saudi Arabia)
- Observational Study (Prostate Cancer) in 10 site, in 4 countries ( Qatar, Kuwait, UAE)
- Web Application delivery to KOL in Algeria for remote management of ¨Patient’s Data
- Health Economic Studies ( Tunisia, Morocco)
Date Job Title
From Jan 2013 until Dec
2017
CRAIII/Team Lead/ Training compliance Coordinator within MCT CRO
The following tasks were handled for the below different Trials:
o Coaching of Junior CRAs ( Egypt, Tunisia, KSA, Lebanon, Algeria Senegal)
o Root cause Analysis and CAPAP implementation within the required timelines.
o Support Junior CRAs to work in accordance with GCP and protocol
requirements
o Supervise the Quality of delivered work (review IMVR, RM…)
o Ensure compliance to sponsor requirements
o Startup activities within different countries (Egypt, Tunisia, KSA, Algeria)
o Project management and Resource development
o Perform Site selection Visit, SIV, IMV and COV
o Performs Accompanied visits with more junior CRAs (training or evaluation)
o Performance measurement
o Support the team in Training issues
o Answer the queries raised by the team regarding Training and compliance
o Assure that All the team member’s training are up to date
o Follow up on training completion
o Coordinate Training and attendance of Training
o Monitoring administrative and logical support.
o Manage TMF, feasibility study, contact with study site team
o Perform monitoring and make sure that the sites are working in accordance
with ICH GCP
Handle IMP delivery to the sites and IMP return to sponsor
o Collect regulatory and administrative documents needed for the constitution of the regulatory file
o Participate to international and/or local investigator’s/CRA meetings.
o Manage relationships with sites.
o Prepare and participates to site audits or system audits.
o Manage Site issues and queries
o Implementation of CAPA
The above is applicable for the following Trials:
- Phase II open label oncology Trial ( 3 site, 1 Patient) within Tunisia
- Phase III Interventional study in Beta Thalassemia ( 9 sites - Hematology, 42 Patient) within Tunisia, Algeria, Saudi Arabia and Lebanon
- Observational Trial in multiple sclerosis ( 4 Sites-Neurology Within Tunisia)
- Phase III international study in Amyloidosis and its extension: (8 sites, 40 patients) within Tunisia and Egypt
- Observational pediatric study about molybdenum cofactor deficiencies: (3 site, 10 patients) within Tunisia and Saudi Arabia