Pre-Clinical Data Manager Siena (Italie) H/F
Descriptif de poste
Keyrus Biopharma is hiring a Pre-Clinical Data Manager.
The person holding this position will participate in various pre-clinical data management activities required to ensure that data captured in pre-clinical trials undertaken are collected, managed and reported clearly, accurately and securely.
In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines.
- Provides general data management support to the project team as needed,
- Responsible for the ongoing maintenance, validation and testing of the preclinical database,
- Provides support to study team in the development of external systems capturing preclinical data,
- Responsible for archiving of the preclinical database and related documents.
- Higher scientific training M.Sc. or Ph.D. (scientific background: biology, biochemistry etc) with knowledge of data management activities,
- At least 2 years of pre-clinical data management experience in clinical research in the biotechnology, pharmaceutical, or contractual research organization (CRO) industry; Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines,
- Extensive experience working with database structures, including demonstrated skills in database programming,
- Good understanding of CDISC SEND standards,
- Highly organized and detail-oriented with effective project planning and time management skills,
- Strong verbal and written communication skills English / Italian,
- Excellent problem-solving abilities, time management, flexibility, ability to coordinate workload and meet established deadlines,
- Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands.
This Job is located in Siena (Italie).