Clinical Process Trainee, Regulatory Start-Up
Under direction of line manager, support the delivery of activities as determined by the appropriate country, regional lead or global lead. May conduct specific tasks under guidance of senior staff. Responsibilities may include all or some of the activities listed at any one time.
- Assist the team in the preparation, handling, distribution, filing and archiving of documentation according to the scope of work and standard operating procedures
- Review documents for completeness, consistency and accuracy, under guidance of senior staff
- Prepare client deliverable documents using appropriate tools and may draft text for straightforward documents, under guidance of senior staff
- Assist with completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project plans with project specific information
- Provide support for administrative tasks, e.g. meeting coordination, minute taking, travel arrangements, faxing, copying, couriers
- Interact with internal and external clients, under guidance of senior staff
- May perform IP release activities on small, straightforward projects or support reviews for larger projects
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Language skills – fluency in English together with a good command of at least one additional language (Polish/German / Portugese/ Ukrainian)
- Good interpersonal communication and organizational skills
- Good word processing skills and knowledge of MS Office applications
- Good attention to detail
- General awareness clinical trial environment and drug development process
- Ability to work on multiple projects
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Higher Education or Life Science diploma with minimum 1 year experience in an administrative environment or equivalent combination of education, training and experience.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Regular sitting for extensive periods of time
- Travel may be required.
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