Nonclinical Data Associate I position located in Germany.
Essential Job Duties:
The Nonclinical Data Associate I is an entry level position in the global data management solutions group, learning the tasks required of drafting and finalizing nonclinical datasets.
- General Duties
- Learns appropriate levels and methods of direct contact with clients
- Learns to prepare form letters and communication text
- Shadows experienced data associates and joins other client-facing staff (e. G., study director) to attend client site visits and client conference calls
- Learns to use software tools to efficiently and accurately complete job duties. Types of software include word processing, spreadsheet, dataset/table generation, collaboration/sharing, and database applications.
- Dataset Preparation
- (85%) Trains on duties required to complete dataset preparation. Tasks to be learned may include, but are not limited to:
- Learning how to obtain and review study documents (e. G., protocol, report) to gather information to prepare datasets
- Learning to generate and quality check (QCing) dataset files to ensure compliance with regulatory requirements
- Learning to address quality assurance (QA) inspection items. Includes learning to identify corrections and respond with detail of actions taken
- Learning to address client inquiries on content of study datasets
- (5%) Learns to compile metadata to populate databases supporting nonclinical safety assessment.
- (5%) Trains on software testing and validation activities. Initial training will include executing test scripts and maintaining documentation in accordance with Covance Unified Systems Life Cycle (CUSLC) methodology which complies with General Principles of Software Validation issued by the FDA.
- (5%) Performs other duties as assigned and may include shadowing or attending company and/or industry initiatives related to dataset specifications and/or production
- (85%) Trains on duties required to complete dataset preparation. Tasks to be learned may include, but are not limited to:
- Bachelor's degree or equivalent experience in Computer Science, Informatics, MIS, Science, or other related field.
- Degree and/or experience in technical writing, document production/publishing, and/or science preferred.
Minimum Required:
- Basic knowledge of office software (e. G., Microsoft® Office, especially Word and Excel; Adobe® Acrobat®).
- Attention to detail, time management skills, and organizational skills.
Preferred:
- VBA programming, XML schemas, analytical programming (R, SAS, Python) or SQL experience.
- Prior experience with SEND, STDM, General Principles of Software Validation issued by the FDA.
- Software validation experience
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