PSI CRO AG
1001 - 5000 employees
Founded 1996
⚕️ Healthcare Insurance
💊 Pharmaceuticals
🔬 Science
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.
Lead Data Manager – Clinical Trials
🔥 0 minutes ago
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PSI CRO AG
1001 - 5000 employees
Founded 1996
⚕️ Healthcare Insurance
💊 Pharmaceuticals
🔬 Science
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.
📋 Description
• Responsible for all data management activities in large, complex studies • Primary communication point for project teams and company departments regarding clinical data management • Co-ordinate/perform user acceptance testing • Development of Data Validation Plan/Edit Check Specifications • Data validation and query generation • Coordination of processing, dispatch and archiving of CRFs/queries • Preparation and attendance at audits/inspections of Data Management • Training of Assistant Data Managers and clinical team regarding CRF completion
🎯 Requirements
• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities • At least 3 years of experience of full scope of data management responsibilities in global EDC studies • At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable) • Project data management experience is a plus • Organizational and managerial skills
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