31 ene
Sanofi
Ciudad de México
Job title:
Clinical Study Startup Specialist
Location: Ciudad de México
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress
.
Join our
Vaccines team
as
Clinical Study Startup Specialist
and you’ll be responsible for managing clinical studies within Sanofi Vaccines R&D.; They assist in feasibility and study start-up across all trial regions, ensuring quality deliverables and of information received, adherence to protocols, and compliance with Good Clinical Practice and company SOPs.
Main responsibilities:
Partner with Clinical Research Organizations (CROs), Clinical Operations teams, and Feasibility partners to improve overall study startup metrics and implement processes.
Coordinates the start-up deliverables of assigned studies in all aspects of start-up (including overall accountability for delivery to time, cost, and quality etc. and communication with relevant stakeholders).
Develop and implement global study startup project plans and manage the collection and analysis of all data to influence study startup timelines.
Provide accurate projections and timelines based on country’s historical performance with the support of the CRO partner.
Monitor start-up activities, identify risks, and manage issues independently, Ensure compliance with local regulatory guidelines and provide support to resolve local issues.
Report progress and challenges in trials to the clinical team during team meetings.
Oversee collection of investigator and regulatory documents for study submissions.
Support negotiations with sites and maintain quality control of study start-up documents.
About you
Experience:
Clinical Trial experience required with proven track record in delivering high quality
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.