Clinical Data Reviewer

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đŸ”„ 11 minutes ago

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Logo of PSI CRO AG

PSI CRO AG

1001 - 5000 employees

Founded 1996

đŸ„ Healthcare

đŸ’Œ Consulting

📩 Logistics

Healthcare ‱ Consulting ‱ Logistics

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.

📋 Description

‱ Review clinical data remotely and identify errors, systemic issues, and trends related to data integrity, participant safety, and site performance ‱ Generate, follow up on, and resolve data queries and site issues ‱ Identify potential protocol deviations ‱ Develop and maintain study-specific Central Data Review tools, templates, and tracking materials ‱ Support the setup and management of risk-based and central monitoring tools and activities ‱ Assist with central monitoring signal review, root cause investigation, and follow-up ‱ Support the Central Monitoring Manager with study data, documents, and reports ‱ Contribute to inspection readiness, including eTMF QC and study archive activities

🎯 Requirements

‱ Bachelor’s degree ‱ At least 1 year of experience in the Clinical Research Industry ‱ Clinical Monitoring experience is an advantage ‱ English proficiency at CEFR B2 level or above ‱ Proficiency in MS Office applications ‱ Analytical mindset and attention to detail ‱ Ability to learn, plan, and work effectively in a dynamic team environment

đŸ–ïž Benefits

‱ Professional development and investment in employees' career success ‱ Remote work option

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