, for each other, and for the future of science, we're in. Are you? About the Role: We're looking for a GxP Clinical Systems IT Owner in the ITteam... Intelligence, you'll be responsible for ensuring that clinical IT systems are implemented, validated and maintained in compliance...
, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a GxP Clinical Systems IT Owner in the IT... of experience in IT/Clinical Systems Validation in Biotech/Pharma Industry. You are or you also have: Strong understanding of GxP...
, for each other, and for the future of science, we're in. Are you? About the Role: The Senior GxP Systems Engineer is a senior technical role... responsible for the architecture, operation, and compliance of regulated laboratory and manufacturing IT/OT systems...
one or more systems in the Clinical space. The System Owner works closely with vendor(s) if applicable, R&D IT (Information Technology... leadership, lifecycle management and continuous improvement of Clinical systems as assigned. The System Owner can cover...
and external partnerships. The Functional Process Owner (FPO) of Clinical System Access Management (CSAM) process is a member... allocated owner for a specific set of Clinical Operations system processes, Functional Process Owner is responsible for: The...
System Owners the CSQM will oversee the quality and regulatory requirements of IT systems across Global Clinical Development... investigational sites around the globe, our Clinical Research systems have to be compliant with regulatory requirements and follow...
is responsible for leading and executing IT risk-based computer systems validation and associated technical compliance initiatives... validation and regulatory compliance execution. The role ensures that IT systems—particularly ACM’s data center infrastructure...
, Biostatistics, Regulatory, Quality, and IT to deliver high quality systems that support complex trial designs and global regulatory... with global protocols/regulations. Ensure robust data flows from IRT/RTSM to other clinical systems; specify interfaces...
architecture, solution design, and technical roadmap for critical GxP systems supporting Clinical Supply Chain, Commercial... during regulatory inspections and internal GxP audits related to the managed systems. Establish and govern processes for Master Data...