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Remote Site Monitor - Lisbon-135633 - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresPortugal,
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Remote Site Monitor - Lisbon-135633

Nr ref.: /JOBS.pl

  • PPD is a leading global contract research organization, providing discovery and development services and drug lifecycle management. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 15,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe, effective therapeutics to patients and maximize returns on their R&D investments.
    The Clinical Development services group is expanding our remote monitoring and site management capabilities. Due to this expansion we are opening up the opportunity to apply for the position of Remote Site Monitor (RSM) in Portugal.Responsibilities:
    Performs remote site management activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and PPD procedural documents.
    Reviews study data from various sources remotely.
    Contacts study sites to collect study documentation, resolves issues and requests outstanding information.QualificationsEducation 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 (comparable to 0-1 year), as well as, knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities. In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.Knowledge, Skills and Abilities:
    Basic medical/therapeutic area knowledge and understanding of medical terminology
    Ability to attain and maintain a working knowledge of FDA and/or local regulation and guidelines, ICH GCPs and PPD procedural documents
    Ability to successfully complete PPD's Clinical Foundation Training Program (CFP)
    Ability to evaluate medical research data
    Ability to advise, counsel, and motivate investigational sites
    Effective oral and written communication skills with the ability to communicate effectively with medical personnel
    Excellent interpersonal and customer service skills
    Good organizational and time management skills
    Proven flexibility and adaptability
    Strong attention to detail
    Ability to work in a team or independently, as required
    Good computer skills with good knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn appropriate software
    Ability to extract pertinent information from all study documents, such as protocols, electronic study data systems, CTMS and dashboards
    Excellent Portuguese and English language skills


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