Randomization Office Specialist

The Randomization Office Specialist is accountable to provide various Randomization office services including approval of randomization list, ensure the compliance of randomization process, verification and release of randomization/medication files working closely with GDD functions and other partner groups. Contribute and responsible for ensuring Randomization data accuracy and integrity, and keep the blinding status during the whole course of trials, all with minimal supervision.

• Gate keep randomization codes ensuring the blinding status is maintained according to the trial protocol.
• Generates and reviews randomization schedules per the protocol and randomization specifications.
• Ensure all the randomization operations is compliance with randomization process. This encompasses randomization, blinding, IVRS usage, regulatory requirements, trial design elements, and current processes / SOP s.
• Perform regular randomization office activities: approval, review, qc, and release of randomization and medication files, assessment of planned/unplanned release requests.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Represent function in cross-organizational and/or GCO initiatives
• Deputize as necessary for supervisor
• Optionally, support other service areas (e.g. Governance of GCO wide corrective actions and preventative actions, deviation management) , etc, as assigned

• State of the art and well controlled processes and practices driving efficiency/productivity, quality, and compliance - measured through KPIs/metrics/Survey feedback
• Timely and accurate maintenance of randomization file processing
• Demonstrated efficiency gains (e.g. reductions in time, cost, risk) to GDD through targeted process improvements in the randomization operations space
• Ensure that customer demands are identified, prioritized and align

• Bachelor s degree or equivalent experience in engineering, mathematics, statistics, computer science, or health sciences/related field

• Fluent English (oral and written)

Clinical Data Management, Databases, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, Waterfall Project Management