JOB DESCRIPTION

Summary:

Execute and support study data transfer activities; database set-up, sample reconciliation, data compilation, and data formatting under limited supervision


Education, Experience, and 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

Essential Function:

  • 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 or SEND format
  • 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


Competencies:

  • Adaptable
  • Flexible
  • Exactness
  • Collaborative
  • Effective Listener and Communicator
  • Capacity to Master
  • Creative and Forward Thinking
  • Initiative
  • Supportive
  • Extend Assistance
  • Client Service Oriented
  • Writing Skills
  • Problem Solving
  • Results Driven
  • Integrity
  • Decision Making
  • Forward Thinking
  • Diplomacy
  • Evaluation Skills

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