- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs and implement initial quality checks independently, ensuring… more
- Repligen (Waltham, MA)
- …Monitoring and ReportingCollect, analyze, and report on monthly supplier performance data , including quality , delivery, and service metrics.Prepare and ... OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier ...of issue details, affected part numbers, quantities, and supplier information. Data Analysis and Trend Reporting: Analyze NCMR data… more
- Formation Bio (New York, NY)
- …to ingest and transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and ... Bio is seeking a hands-on technical leader to shape the future of our Data Platform. This role is ideal for someone passionate about building scalable infrastructure… more
- Merck & Co. (Rahway, NJ)
- …Perform independent quality review and approval of batch records, testing data , and related documents required to release or reject product. Make independent ... metrics by summarizing findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support… more
- Genmab (NJ)
- …consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making. ... authorities or ethics committees, answers to in-house questions related to data quality , safety monitoring, medical questions etc.Performs sponsor oversight… more
- Merck & Co. (Rahway, NJ)
- …principal component analysis, etc.Develop and implement statistical process control methodologies and data anlaysis to ensure the quality and reliability of ... Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product… more
- Merck & Co. (Rahway, NJ)
- …patients and global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight ... and quality management of submission data standard deliverables for world-wide regulatory application submissions of...tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and continually improve data representation and delivery applications (including data quality ) in support of US Talent Acquisition Evaluates processes ... activities for US Talent Acquisition. Responsible for oversight of master data and data integrity related to US Talent Acquisition. Ensures utilized solutions… more
- Eisai, Inc (Nutley, NJ)
- …capabilities to independently carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong ... profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance...preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years of experience… more
- Merck & Co. (North Wales, PA)
- …collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of ... medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with the Clinical Director.Other responsibilities… more
- Merck & Co. (Rahway, NJ)
- …collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of ... Leading medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in collaborations with the Clinical Director. Other… more
- Merck & Co. (Rahway, NJ)
- … data analysis.Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.Collaborates ... Late Development Statistics. --Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other company Research Laboratories Scientists in… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... & Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better practices, to include… more
- Merck & Co. (South San Francisco, CA)
- …leads the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused on bringing AI/ML approaches to bear to improve the ... speed and quality of decision-making in drug discovery and development. PDMB...of GenAI solutions with PDMB's scientific processes. -Work with data engineers and architects in IT to build a… more
- Formation Bio (New York, NY)
- …that adheres to CI/CD and data governance best practices. Implement data validation and observability frameworks to ensure quality , trust, and ... and more efficiently.About the PositionWe're looking for a Senior Data Engineer to join the Data Platform...AI. While your initial focus will be on building high- quality EHR models for Formation Bio platform, you'll also… more
- Twist BioScience (South San Francisco, CA)
- …solutions across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated ... data visualization capabilities to support operational decision-making and quality reviews.Compliance & Validation: Ensure our custom MES solutions comply with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... with us? The PositionThis role reports directly to the Vice President of Enterprise Data & Advanced Analytics (ED&AA) and serves as a key member of the Novo… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …utilities, and facility qualification, process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight ... development of validation and qualification related policies, procedures, templates, formsProvides quality oversight on data integrity of systems, instruments,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
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