Nonclinical Data Associate I
3 days ago
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 with supervision.
- 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
- 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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