Category

Description

• 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.

• 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.

• 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 English language and grammar skills

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