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Clinical Trial Documentation Associate Sofia Bulgaria,  


Posted on : 13 June 2017

Project Description

Location: Warsaw and Sofia (office-based) The duties associated with the role include:   Assisting with the development and oversight of Trial Master File document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established procedures and policies. Preparing and is responsible for maintaining assigned Trial Master setup based on provided Document Management Plan. Preparing files from TMF according to communicated deadlines. Monitoring the TMF routinely for document availability using defined tools and/or routine procedures according to agreed upon metrics and performs escalation per process definition. Performing quality control of assigned TMF parts per documented schedule. Participating in preparation of the completed studies for archiving. Reporting about unresolved problems that appear during the cooperation process. Requirements:   Minimum of six (6) months of clinical research experience Knowledge of GCP including a basic understanding of regulatory requirements University / college degree Administrative skills Fluency in English Eagerness to learn medical / clinical research vocabulary and procedures Excellent organization skills, patience, attention to detail Very good communication skills Teamwork ability Computer competency If you wish to apply, please submit your CV using the button below.

Locations

Warsaw PolandSofia Bulgaria

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