Clinical Study Administrator assisting in the coordination and administration of study activities. Joining Parexel to improve global health through clinical trials and regulatory consulting.
Responsibilities
Assist in the coordination and administration of the study activities from the start up to execution and close out
Work within the Local Study Team (LST)
Ensure quality and consistency of interventional study deliverables to time, cost and quality objectives
Trial and site administration and support
Document Management (eTMF, ISF)
Regulatory & Site Start-Up responsibilities
Budgeting, Agreements and Payments
Requirements
High school/Secondary school qualifications
Further studies in administration and/or in the life science field are desirable
Previous administrative experience preferably in the medical/ life science field (minimum 6 months)
Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it
Understanding of the ICH-GCP guidelines
Proven organizational and administrative skills
Computer proficiency
Proficient in written and spoken English language required
Fluency in local language(s) required
Ability to develop advanced computer skills to increase efficiency in daily tasks
Good verbal and written communication
Good interpersonal skills and ability to work in an international team environment
Willingness and ability to train others on study administration procedures
Excellent organization and time management skills
Excellent attention to detail
Ability to multi-task in a high-volume environment with shifting priorities
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
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