Remote Site Monitor, Czech Republic

Description
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.


Qualifications
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.

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

If you feel that you have the necessary skills and abilities to be successful in this role but are unsure if you qualify for the position, please do speak to your Country Head for further guidance.