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IT Compliance Specialist

4 days ago

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Logo of PSI CRO AG

PSI CRO AG

Healthcare Insurance ‱ Pharmaceuticals ‱ Science

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

1001 - 5000 employees

Founded 1996

⚕ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

📋 Description

‱ Focus on compliance matters related to in-house IT systems and processes ‱ Work with documents to ensure PSI meets standards, industry requirements, and internal policies ‱ Create, update and process internal IT documents (change control, risk assessment, computer system inventory, validation, disaster recovery plan) ‱ Generate and provide IT documentation for internal and external audits ‱ Take part in IT interviews during internal and external audits ‱ Provide answers to IT questions from sponsors ‱ Follow up on resolution of audit findings related to IT compliance ‱ Support development and update of IT-related documents ‱ Participate in the development of departmental QSDs ‱ Monitor and ensure compliance with PSI QSDs, relevant laws, regulations and standards ‱ Participate in regular risk assessments to identify potential vulnerabilities in IT systems and processes

🎯 Requirements

‱ College or University degree ‱ Prior experience in IT and compliance matters ‱ Meticulous, able to work with documents and processes ‱ Full working proficiency in English

đŸ–ïž Benefits

‱ Professional development opportunities ‱ Remote work options

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