Mes compétences :
Industrie pharmaceutique
Qualité
Gestion de projet
Gestion de la relation client
Essais cliniques
Entreprises
PRA Health Sciences
- Clinical Team Manager III
2014 - maintenant
ICON plc
- International Clinical Trial Manager Level 2
2012 - 2014Functional lead accountable for the execution and delivery of clinical operations activities in EU countries
• Monitoring the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
• Manage study communication and issue escalation within the EU team
• Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements. Oversight of submission process to regulatory and/or ethic committee
• Management and maintenance of the trial budget(s).
• Define and ensure appropriate resource requirements.
• Input on or establishment of procedures or study documents to ensure adherence to protocol and other requirements (like ICH GCP, or SOPs).
• Accountable for creation, maintenance and oversight of EU TMF all trial files.
• Provision of regular and ad hoc information, both written and verbal, to all the trial participants / sponsors. Study performance reporting to upper management.
• Leading protocol deviation review and follow-up task at study level (all regions, including meetings with sponsor).
• Vendor management: preparation of scope of work, vendor oversight, and assessment.
• Involvement in inspection and audit answer reports.
