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. Software types to include: word processing, spreadsheet, dataset/table generation, collaboration/sharing, and database supportive 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 (QC) dataset files to ensure compliance with regulatory requirements
Learning to address client inquiries on content of study datasets
(5%) May learn to compile metadata to populate databases supporting nonclinical safety assessment.
(5%) May train on software testing and validation activities. Initial training will include executing test scripts and maintaining documentation in accordance with Systems Life Cycle methodology which complies with General Principles of Software Validation issued by regulatory agencies.
(5%) Performs other duties as assigned and may include shadowing or attending company and/or industry initiatives related to dataset specifications and/or production
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