Clinical Data Manager

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September 9

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PSI CRO AG

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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

• Track database set-up, testing, maintenance and data entry • Communicate with clients, project teams and vendors on data management matters • Review study documents, design and develop project specific guidelines and instructions • Design eCRF, Data Management and Data Validation Plans and test EDC databases • Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation • Code medical data • Track and report metrics leading to database lock • Coordinate the processing, dispatch and archiving of CRFs/queries • Maintain Clinical Data Management working files • Perform database QC checks, prepare and attend audits • Train site staff and project teams on CRF completion and data management topics • Play a critical role in clinical research projects working with large volumes of clinical or medical data

🎯 Requirements

• College/University degree (Life Science, Pharmacy degree is a plus) • Demonstrated experience of managing clinical or medical data • Full working proficiency in English • Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm) • Proficiency in MS Office applications • Organisational and time management skills • Ability to work independently and multi-task • Submit CV in English • Based in Brazil

🏖️ Benefits

• Employees can work remotely