Clinical Trial Documentation Associate - Bulgaria
- 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.
- 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