PUTEAUX
LEADERSHIP & TEAM/PROJECT MANAGEMENT:
-Bid Defence Meetings leading
-Vendor/Client Selection/Management, Proposal analysis, discussion
-MV Reports review
-Audit/Inspection Preparation
-Project Coordination activities (Start-up, Monitoring, Data Management, CRF collection, Central Reading, IXRS, Filing, Data Base Lock, EOS) Europe & Asia
-Planning Set-up/update
-Mentorship, Coaching, Training & Work Direction of local team members, CRA/Freelance CRA, including leading of one to one/Project Meetings, acting as point of reference for operational & role-specific questions
-Conduct of Accompanied Field Visits, Authorization, Assessment visits.
-Providing of feedback on tools, processes & procedures, identification, suggestion on local & Global EMEA process improvements (i.e.: CTMS, EDC, Essential Documents, Filing, Communication, Visit Reports/Check-lists, Data Base, Templates Drafting, etc)
-Development of phoning guides (French, English), Newsletter drafting
-Collaboration with Sponsors in Business implementation, accompanied visit to meet Local identified KOLs
-Reporting of study progress to study management & Sponsor
CTMS/EDC:
-URS drafting
-Software testing, evaluation, implementation
-Vendors Selection and evaluation
-Software improvement working-group leading
-Bid defence meeting leading
-Contract negotiation
-CTMS Super-user Backup
-Point of reference between Clin Dev & IT department.
Used/Tested software: EDC (Phase Forward, RAVE, PPD), CTMS (Siebel, Clinbase, Onpoint, Medidata).
Spécialités : Feasibilities, Epidemiological, Observational, International Trials (Phase II, III, IV) in accordance with ICH-GCP, Local regulation, FDA guidelines, SOP & monitoring guidelines
-Ability to manage simultaneously several projects with different Therapeutic Areas, timelines
-Communications Skills
-Ability to learn quickly
-Dynamic, Proactive, Organized
Trainings:
Management Basics, Stress Management, Improvement on communication Skills, Audit Readiness, Team Building
Mes compétences :
CRA management
CRO
ICH-GCP
eCRF-CTMS
project coordination
SOP
FDA
Clinical trials
Startup
International
Coordinator
Industrie
Recherche
Research
Management
