- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal ... Data Management deliverables meet/exceed project/study team expectations regarding quality , time, and cost and that Data Management documentation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, ... by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined...optimal approaches to support the collection of diverse external data types.Advises Study Data Manager … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality rules and data governance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality .Establish strong partnership with Functional and Regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. ... retention and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of… more
- Merck & Co. (Rahway, NJ)
- …, biomarker data , and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.- ... Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine… more
- Novo Nordisk Inc. (San Antonio, TX)
- …The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... services/tasks in support of the planning and implementation of quality driven clinical trials, in line with...relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...services/tasks in support of the planning and execution of quality driven clinical trials in line with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work...including advocating for good data governance, stewardship, data identification, and data quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, ... collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined...meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical ... and TLFs transfers for ongoing and complete trials, confirm data use and output quality , proactively ensure...and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory… more
- Eisai, Inc (Nutley, NJ)
- …Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...efforts of Translational Science to generate useful human biomarker data sets from internal (eg clinical samples,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process… more
- Merck & Co. (North Wales, PA)
- …least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across various departments of Daiichi… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
