Sr. Start Up Specialist - Clinical Research Sênior
Técnico / Operacional
Please read carefully the description below prior to your application.
The Sr. Country Approval Specialist will manage the preparation, review and coordination of Ethics Committee and Regulatory submissions and will coordinate all activities to get investigational sites ready to enroll patients in our clinical trials. Duties include but not limited to:
• Preparation, reviewing and coordinating national ethics, regulatory and other relevant authority submissions in alignment with national regulations and global submission strategy
• Providing local regulatory strategy and advice
• Acting as a key contact on a country level for all study related activities during start up and provide oversight to project management.
• Being accountable for bringing qualified sites to the status of ‘ready to enroll’
• Additional tasks in line with business and department needs, also outside the daily CAS tasks as applicable
• Bachelor’s degree in a life science subject
• Submission experience and a good knowledge of applicable local requirements
• Basic medical/therapeutic area and medical terminology knowledge
• Excellent communication and organizational skills and a self-motivated, flexible and professional attitude
• The ability to handle multiple projects and tasks effectively, often within strict deadlines is essential
• Fluent English language skills
Experiencia na submissao de pacotes regulatórios na pesquisa clínica
08:00h às 17:00h
Compatível com o Mercado
Itaim Bibi São Paulo - SP
Sobre o Contratante
PPD DO BRASIL SUPORTE A PESQUISA CLINICA LT
EMPRESA MULTINACIONAL PRESTADORA DE SERVIÇOS NA AREA DE PESQUISA CLINICA.
Visite nosso site www.ppdi.com
Posição: Sr. Country Approval Specialist
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