Data Manager- Need Pharma, Biotech or CRO Experience

4 weeks ago

Malvern, United States Resolian Full time

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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