• trial set-up and maintenance, and/or derived dataset, table, listing, and figure programming and/or implementation of system applications and upgrades/changes to those applications as required in accordance with corporate quality standards, WSOPs / Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
• Check own work in an ongoing way to ensure first-time quality.
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
• Proactively participate in quality improvement initiatives.
• Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.

• Provide relevant training and mentorship to staff and project teams as appropriate.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
• Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
• Use efficient programming techniques to produce and/or QC low-medium complexity derived datasets, tables, figures and data listings.

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