Paris2013 - maintenantSince july 2014
Phase IIIb - Type2 Diabetes - set-up (19 countries)
Conduct of study set-up activities:
- Budget: planning and monitoring
- Development of study plans (recruitment, monitoring, data management, risk) and study documents (training, device user manual)
- Selection and management of external providers: data management, e-diary, IVRS, central laboratory
- Trial management: Coordination of sites initiation of 190 sites
Implementation of an e-diary adapted to elderly population:
- Design and data flow: data collection in e-diary, view in vendor’s portal, transfer in clinical database
- Supply strategy: Development of the distribution plan. Coordination of the implementation with local contacts according to local regulation
Transversal activities:
- Close collaboration with purchasing, e-CoA/e-PRO manager and e-diary provider to improve the implementation of an e-diary in Diabetes studies: reporting of issues and risks identified with action plans implemented and/or new proposal.
june 2013 - june 2014
Phase III - Type2 Diabetes - DB lock (13 countries)
Trial Management on 2 similar studies with 1 interim and 2 final DB lock in 6 months. Responsible for the coordination of end of study activities until site close-out procedures.
Data cleaning: Review of validation listings and control of missing data. Involved in the data review and surveillance in collaboration with Biostatistics department.
Transversal activities at program level (7 studies):
Review board management:
- Leader for operational activities related to the review of hypoglycemic events.
- Communication with the members of the board including the planning of the review according to study timelines.
- Coordination of activities from the preparation of dossier submitted to the committee to the validation of data entered in the clinical database.
PAI readiness:
- Review of study documents / process (FDF, FDA1572 submission, training, etc)
- Preparation of documentation for the Clinical Study Report, and for audit and inspection in collaboration with Quality Assurance and Medical writing.
