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Clinical Trial Management System Support

Business Type: Clinical Research Organisation
Job Type: Clinical Research
Job Level: Experienced (non manager)
Position: Full Time
Location: Cambridgeshire
Reference: CMSS
Job Details:

At a Clinical Trial Unit located in Cambridge, Phase 1 and first time in human studies are conducted. We are seeking a motivated individual with a keen eye for detail to provide system support activities to a Clinical Trial Management System. Full training in the system will be provided. In this role you will:

· Be responsible for setting up the data capture interface and schedules to capture data for clinical studies based on study protocols, whilst maintaining accurate study setup records.

· Ensure system is compliant with current regulatory guidelines and is in inspection ready validated state, responding to environmental changes e.g. Microsoft/SQL Server platform changes and end user change requests.

· Ensure provision of data to study teams and conducts database release and freeze activities. Responsible for the delivery of the outputs requested within the timeframe requested, prioritising activities appropriately.

· Ensure that studies are setup to enable the study to be conducted and archived according to Human Biological Sample Management standards, ICH GCP, Ethical, Regulatory requirements and GSK Policies and Procedures.

· Maintain accurate and complete records consistent with company policy and legal and regulatory requirements.

· Demonstrate sound scientific and ethical judgment to ensure that clinical studies are conducted in the correct ethical and scientific manner, adequately documented and any deviations or discrepancies dealt with contemporaneously.

· Collaborate with other teams/divisions within the unit and external partners/collaborators.

Posted: 20/05/2021 | NPJ Ref: 270947