Clinical Project Lead
SANOFI
Total des années d'expérience :11 years, 6 Mois
Supervision ofl clincial activities within the clincial operation team.
Coach the CRA on the ebst practicies in achieving successfull projects as well as self and team development
Vendor management (selection of CRO, bidding process, contract maangement)
Budget holding and annual reconciliation (phasing / accruals)
Safety reconciliation
SOP creation
- Study feasibility on selected centers
- Development of Informed consent, Case report form, Quality life questionnaire, patient card
- Studies are referenced and approved by THICS COMMITTES following the National BIOETHICS requirements
- Submission and / or Notification of studies to competent authorities SFDA / MOH
- All investigators selected has contracted an agreement following guidance
- Study agreement / contract creation
- Site selection process according international ICH-GCP requirements
- Study site initiation and investigator meeting plan
- Maintain training of study site staff on study protocol
- avoid protocol deviations
- Site follow up on weekly basis
- Supplying study sites with study documents (CRF, ICF, etc…)
- Smooth process of Quality control visits and monitoring
- Control process of ICF collection from the patients by investigator following GCP
- Check patients’ source data and medical file for monitoring to ensure data accuracy
- Collection of completed CRF and destruction of unused documents
- Contracting with Research Organization (CRO)for performing data analysis and data management plan
- CRO training about all protocol to start data analysis and data management plan
- Study update and follow up on weekly basis, monthly basis
- Sending Newsletters to investigational sites
- Phasing of the study budget and payment orders
- Site closure and destruction of unused documents
- Control of archiving of Study File in secured place as per ICH-GCP guidance
- Data resolution process (DCF)
- Lock the data base
- Review statistical analysis report and data raw
- Coordinate with CRO for clinical study report writing
- Submit clinical study report to principal investigator for review and approval
- Archive Trial master file with whole study documents as per local and ITC guidance.
-Budget break down
-Study feasibility on selected centers
-Submission and / or Notification of studies to competent authorities
-Study agreement / contract creation
-Site selection process
-patient randomization
-study documents supply
-electronic CRF cleaning
-payment of site
-archiving
-Study feasibility on selected centers
-Submission and / or Notification of studies to competent authorities
-Study agreement / contract creation
-Site selection process
-patient randomization
-study documents supply
-electronic CRF cleaning
-payment of site
-archiving