Central Review Mgr

hace 2 semanas


Ciudad de México Thermo Fisher Scientific A tiempo completo

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

Education and Experience: - Bachelor’s Degree in a life science-related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities. - Prior clinical research experience with a minimum of 2 years on site clinical monitoring. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Good therapeutic area knowledge and understanding of medical terminology by virtue of past training of a CRA Ability to attain and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP) Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Ability to work in a team or independently or as home based, as required Ability to write clinical monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports Ability to extract pertinent information from protocols, electronic study data systems, CTMS, dashboards and assess risk at site level through interpretation of all these data Excellent English language and grammar skills Ability to mentor junior team members, as needed.


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