other trail related documents and other required documentation in compliance with project plans, federal regulations, GCP and good... and competitive trends. Deliver high quality scientific presentations on Exelixis investigational agents to physicians and other key...
research, test and implement quality systems, processes and procedures within CQA area Develop and assess GCP metrics..., conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities...
audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory... and assess GCP metrics, conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA...
releases on schedule with the highest quality standards. Demonstrate the company's core values of respect, honesty, integrity... & procedures, regulatory compliance & conduct ongoing performance audits & take action - Must be able to perform the essential...
relating to verification and validation of molecular tests and quality system elements Any other duties deemed necessary... and clinical studies (GLP and GCP) Experience or knowledge of the requirements on working in a FDA regulated environment...
and GCP compliance Assist in the development of contingency/risk management plans and associated mitigation strategies... for proposal submission, CRO selection, and the day-to-day operational management activities of CROs Oversight of study quality...
and GCP compliance Assist in the development of contingency/risk management plans and associated mitigation strategies... for proposal submission, CRO selection, and the day-to-day operational management activities of CROs Oversight of study quality...
for reliability, data quality, and stakeholder value delivery. Provide technical leadership; guide architecture, solution design..., reliability, MTTR, data quality, delivery predictability, stakeholder satisfaction). Lead discovery, scoping, and iteration...
releases on schedule with the highest quality standards. Demonstrate the company's core values of respect, honesty, integrity... & procedures, regulatory compliance & conduct ongoing performance audits & take action - Must be able to perform the essential...
consistent, high-quality delivery in compliance with enterprise data governance and security standards. Stakeholder Engagement..., you will champion Agile values, optimize team performance, and ensure the on-time delivery of scalable, high-quality data solutions...
and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality... with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality...
as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the..., whilst enabling compliance with regulatory requirements. Assist with the creation and/or review of core scientific...
). Stay current with ICH-GCP, regulatory standards, and TMF industry updates to ensure ongoing compliance and best practices... Master File (TMF) in alignment with Genmab’s procedural documents, ICH-GCP guidelines, and regulatory authority expectations...
and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality... with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality...
key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns. Establish... and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations...
and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality... with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality...
with external vendors or internal teams. Perform quality control and audit activities to ensure data accuracy and compliance... guidelines (e.g., FDA, ICH, GCP) and company standards for data management. Perform data cleaning, query resolution...
and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality... with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality...
for Business Unit(s) to enhance data quality and advanced analytics for transformation. This role shapes demand for data science... and compliance. Preferred: manufacturing experience, operations, supply chain, and knowledge of modern data architectures...
. Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations. Contribute... management and query resolution. Conduct data validation checks and implement quality control measures to ensure accuracy...