Ensure quality control (QC) on all process and technical activities related to:
- 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 ***-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.
-Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial -Management System (CTMS), Safety Reporting, SAS and other programming language usage and processes within the GRO, biostatistics, and medical arenas.
-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.
Experience:
*** degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.
Excellent written and oral communication skills.
Relevant Clinical Trial industry experience
Experience working with systems used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting)
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