, for each other, and for the future of science, we're in. Are you? About the Role: The Lead IT Systems Engineer (GxP) is a senior technical role... responsible for the architecture, operation, and compliance of regulated laboratory and manufacturing IT/OT systems...
management and continuous improvement of Clinical systems as assigned. The System Owner can cover one or more systems in the... Clinical space. The System Owner works closely with vendor(s) if applicable, R&D IT (Information Technology), Functional...
SUMMARY: The Clinical Technology, IT is the accountable owner for the strategy, delivery, and operational integrity... of information systems supporting 4DMT's Clinical Research and Development organization. This role ensures clinical systems are fit...
with internal and external systems, including CROs, labs, and regulatory partners. Assume the role of a system owner (ITSO...Make your mark for patients We are looking for a Digital Technology Lead, Clinical Analytics to join our Digital...
. Lead the R&D application upgrades and implementations as the IT System owner Manage and oversee user administration... for GxP applications Qualifications Bachelor's degree in Computer Information Systems, Business Administration or related...
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...
research and clinical data, promote FAIR principles, and influence platform architecture and Governance, GxP & Responsible... research, preclinical work, and clinical development. This role will partner closely with R&D teams to translate scientific...
research and clinical data, promote FAIR principles, and influence platform architecture and Governance, GxP & Responsible... research, preclinical work, and clinical development. This role will partner closely with R&D teams to translate scientific...
, Quality, TCO, serviceability) Knowledge of GxP, pharmaceutical manufacturing, and automation systems About the... Objectives/Deliverables: Service Ownership: Act as the primary owner for Central Quality Solutions, including Vault Quality...
with tools and platforms used in Clinical Development and Portfolio Management, including systems for study planning, execution... with responsibilities in business department and/or IT projects as project owner. Demonstrated experience in leading diverse teams...
of the equipment, systems, and utilities of a GMP Manufacturing Facility. This role dedicates approximately 50% of it's time... has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell...
technical leadership for environmental control systems that underpin GxP, CLIA, CAP, and ISO compliance, ensuring controlled... across sites. Partner with Quality to ensure control systems meet GxP, data integrity, and audit expectations. Act as the...
, 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...