Data Manager – Clinical Trials

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PSI CRO AG

WebsiteLinkedInAll Job Openings

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

• Acts as a communication line for project teams regarding clinical data management • Maintains TMF/eTMF • Trains Assistant Data Manager • Is involved in clinical data management activities including, but not limited to: Supporting development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable) • User acceptance testing • User access management • Data review eCRF/External data reconciliation • Medical coding (for staff with medical/Life Science background) • Supporting SAE reconciliation • Query management • Local lab normal ranges entry and QC • Study Database Lock activities • Archival of CRFs • QC Data entry/QC • Project status reporting • Data listings/Patient profiles generation and delivery • Assisting with Database Lock tasks as needed for assigned projects

🎯 Requirements

• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities • A minimum of one year of industry experience, preferably working with clinical or medical data