Data Manager- Need Pharma, Biotech or CRO Experience
4 weeks ago
Execute and support study data transfer activities; database set-up, sample reconciliation, data compilation, and data formatting under limited supervision.
Responsibilites
· Advise and/or assist with study set-up within LIMS
· Create custom result templates within LIMS for export of study data
· Compile test files and data in accordance with data transfer agreement and CDISC standards
· Peer review test data files against study requirements to ensure correct information is being captured and conveyed
· Oversee data transfer process, tracking and managing internal and external reviews to ensure timelines are met
· Oversee data transfer process lifecycle; including template set-up, test data generation and execution, addressing QA audits, and submission of data to clients
· Prepare and submit interim and final data, as well as inventory files as requested
· Perform data reconciliation activities
· Work with the project team regarding requested data submissions; file type, associated timelines, and potential cost
· Evaluate and establish processes to improve quality and efficiency
· Review and author SOPs
· Follow applicable SOPs, procedural documents, and regulatory requirements
· Understand regulatory requirements; GLP, GCP, OECD, EMA, 21CFR Part 11
· Record tasks in accordance to Good Documentation Practices (GDP)
· Other tasks as assigned
Education, Experience & Skills Required
- BA/BS degree in science or related field; all experiences will be evaluated
- Knowledge of LIMS and/or data management programs
- In-depth knowledge of Microsoft Office
- Able to work in a regulated environment
- Able to work effectively and contribute within a team
- Able to work with computer systems
- Able to document clearly
- Knowledge of and experience in a regulatory environment
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