YOUR CONTRIBUTION
As Clinical IT Oversight Manager (m/f/d) you will ensure that IT service providers and their systems used in clinical trials comply with applicable laws and regulatory guidelines, including GCP and the EU Clinical Trial Regulation. Acknowledging the advancing digitization of clinical trials with demanding regulatory requirements, your role will be essential to gain sponsor oversight and inspection readiness. As valuable partner for our study specific process owners and key contact for our service providers, you will make certain that we have adequate overview and documentation for our software-as-a-service solutions, that the computerized processes are setup and monitored properly, that the systems are maintained in a valid state, and that user access is suitable. As an expert in the department Global Clinical Data Management & IT, you will closely interact with colleagues from Global Clinical Development, Product Safety, and QA.
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IT system oversight: Create and maintain IT system inventory, organize top level system descriptions, identify and manage compliance gaps, organize periodic system re-evaluations, and contribute to audits.
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Set up Processes: Initiate, track, and contribute to sponsor processes during system setup such as risk assessments, user requirement specifications, and user acceptance tests.
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Change Management: Interact with service providers on planned and conducted system updates. Support risk assessments of system changes and issue management.
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Essential records: Support identification, transfer, and archiving of essential records, as applicable for the IT systems and service providers.
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Process requirements and documentation: Initiate and track processes like user training and audit trail reviews, document these centrally, and support the Clinical Trial Team with eTMF documentation.
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Improve internal Processes: Develop and enhance oversight processes, SOPs, and templates per legal/regulatory requirements.
