Senior Regulatory and Start Up Specialist (Argentina)

Precision Medicine Group

Argentina

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring our first Senior Regulatory and Start Up Specialist (Senior RSS) in Argentina! As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation. The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guid

Requisitos

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring our first Senior Regulatory and Start Up Specialist (Senior RSS) in Argentina! As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation. The Senior RSS may act as Subject Matter Expert for q

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