and MHRA regulations Demonstrated experience using various EDC, CTMS and eTMF (Veeva, Agatha) systems. Experience... required Document reviews in relevant systems with a focus on inspection readiness Working knowledge of relevant GCPs and FDA, EMA...
facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The... of the Hillsboro IT OT team, you will report to the Manufacturing Systems Development Lead to support the Manufacturing...
-on experience with Electronic Data Capture (EDC) systems such as MedNet, Rave, and Veeva Vault EDC. Proficiency in data review...) of clinical databases, including EDC systems. Manage EDC User Access for all assigned studies. Provide day-to-day support...
, and Veeva TMF and RIM. Experience operating systems in Google Cloud environments. Strong vendor management and service... of information systems supporting 4DMT's Clinical Research and Development organization. This role ensures clinical systems are fit...
, and procedures in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems... Details oriented Extrovert Collaboration Day to day: Mailbox monitoring-Veeva mailbox to check the task Accept the asisgnment...
Job Description: WHY THIS ROLE You'll own the systems that keep quality and manufacturing running..., and other enterprise systems so data flows automatically and audit trails stay clean. You'll work across teams (QA/RA, IT, Operations...
required: Expert-level proficiency in configuring and architecting all facets of Veevasystems, including security, documents, objects... of innovative and interoperable clinical systems that drive a robust evidence generation program. Architect object-focused clinical...
. Strong written and verbal communication skills. MUST have experience with CTMS, Veeva Vault eTMF, and eCRF systems. Ability... documents from start‑up through site activation. Maintain accurate and timely documentation within eTMF (Veeva Vault). Track...
with Good Manufacturing Practices (GMP) regulations, including, but not limited to maintaining quality systems aligned with CGMP..., GDP, and regulatory standards, and ensures product compliance through robust quality systems. This role fosters...
-related systems (Veeva, Xponent, APLD, PTD, SR, SNR, or similar). Experience supporting both US and International commercial.... Strategic thinking & systems mindset Analytical and conceptual problem-solving Cross-functional collaboration Stakeholder...