職位描述
職位描述：
Deliver best value and high quality service. 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 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.
-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:
- First 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)
