- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleThe Associate Director, External Data Quality Management , is a strategic leadership role within Clinical ... external vendor management a plus.Proven expertise in protocol design, data quality management , and protocol deviation oversight.Strong knowledge of EDC… more
- Merck & Co. (Rahway, NJ)
- …Standardization, Business Support, Collection Processes, Customer Centric Focus, Dashboard Reporting, Data Quality Management , Direct Marketing, Global ... the Travel, Meetings, Card & Fleet organization within the Global Supplier Management Group (GSMG). This role reports to the Director, Global Procurement Strategy,… more
- Merck & Co. (Rahway, NJ)
- …of 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 drug and vaccine clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high ... standards of data quality and compliance within Global R&D...to foster a culture of compliance and accountability in data management practices. The position also involves… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming ... diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in... data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees… more
- BioAgilytix (Durham, NC)
- …building a high-performing data management team, identifying roles in data engineering, quality , and automation as the function matures.Sponsor Data ... a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of clinical development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations for ... oversight of CROs pertaining to laboratory data management , LNR collection standards, and quality issue...data management , LNR collection standards, and quality issue management .- Collaborates with laboratory DM… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are consistent and regulatory compliant across studies and ... Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of...This position also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, ... risk management principles in design (and resolution) of key quality management system elements to ensure complianceTracks and trends deviations and… more
- Aequor (Swiftwater, MN)
- …management and timely resolution of technical - Responsible for the master data management process including the updating of specifications and supporting the ... Management System [LIMS] Business Administrator is essential to Quality Operations at the Swiftwater site for supporting the...environment - Experience in system testing, validation, and master data management - Familiar with 21CFR part… more
- Formation Bio (NC)
- …to ingest and transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and ... compute strategy, access control, and CI/CD pipelines. Establish standards for data governance, observability, and metadata management . Ingestion & … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams ... safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness… more
- Tris Pharma (Monmouth Junction, NJ)
- …in medical writing software and templates (ie, EndNote, Starting Point, etc.)Experience with data management and quality assurance processesWe are a HYBRID ... research protocol and amendment developmentSupports regulatory submissions by preparing high- quality documents meeting regulatory requirementsStays current with industry standards/advancements… more
- Merck & Co. (Rahway, NJ)
- …and our company's requirements while driving continuous improvement in Device Supplier Quality Management .- Accountable for other Quality Programs, as ... touch every aspect of our business processes, systems, and data .The Associate Director will collaborate and interact with cross-function...820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management System documents for the … more
- Aequor (Thousand Oaks, CA)
- …actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will ... of equipment in area of expertise. 15. Extensive knowledge and application of SAP Quality Management (QM) Module 16. Advanced skills in solving complex problems.… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Regulatory Compliance, Policy Development, Process Facilitation, Process Improvements, Quality Improvement Programs, Quality Management , ... Job DescriptionOur Quality Assurance Group ensures every single material inside...in a pharmaceutical or biotechnology manufacturing site.--Strong background in data analyticsDemonstrated ability to creatively use multiple methods of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experienced quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Eisai, Inc (Nutley, NJ)
- …(CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice ... preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for… more
- Repligen (Waltham, MA)
- …and rollback testing on products as part of lifecycle management validationVerify hardware-software interactions, including connectivity, data acquisition, ... OverviewWe are seeking a detail-oriented Software Quality Test Engineer to join our team. In...work closely with software developers, hardware engineers, and product management teams to validate that our integrated systems meet… more
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