The Nonclinical Data Associate I is an entry level position in the Early Development global data management solutions group, learning the tasks that contribute to drafting and finalizing nonclinical datasets with supervision.
Learns to use software tools to efficiently and accurately complete job duties. Software types to include: word processing, spreadsheet, dataset/table generation, collaboration/sharing, and database supportive applications.
(90%) Trains on duties that contribute to 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 dataset files, including manual data entry as needed
Learning to quality check (QC) dataset files to ensure compliance with regulatory requirements
(5%) May train 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 regulatory agencies.
(5%) Performs other duties as assigned
Education/Qualifications: Bachelor’s degree or equivalent experience, preferably in one of the following: life sciences, computer science/information systems, statistics, or mathematics.
Experience producing SEND or CDISC/SDTM datasets
Advanced knowledge of office software (e.g., Microsoft® Office, especially Word and Excel; Adobe® Acrobat®)
Fluent in spoken and written English
Attention to detail, time management skills, and organizational skills
Knowledge of or experience working on nonclinical studies to proficiently identify details or issues in data that need resolution
Knowledge or experience using programming applications or formulas such as, but not limited to: SAS, R, Python or willingness to learn within 1 st year of employment.
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