- Aequor (Thousand Oaks, CA)
- …for purpose dataset - plan, build, review with the end in mind (protocol - data collection - data review - analysis - archive) New Technology Design and ... job seekers) Remote- open market rate Purpose: To provide expertise in data management processes, demonstrating capabilities & new ways of working, to assist… more
- Eisai, Inc (Nutley, NJ)
- …Clinical Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes ... and end user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical… more
- Genmab (NJ)
- …reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT ... discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically ... variables and processes, and build appropriate mitigations. Drive interface with Integrated Data Review , Data Surveillance, targeted source document… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical or medical lead and biostats to ensure availability of necessary data - Coordinate author review /approval internal review approval- ... in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author… more
- Aequor (West Greenwich, RI)
- …GMP operations and Environmental/Water monitoring. 2. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory ... responsible for activities including microbiology & analytical testing, sample and data management and equipment and instrumentation operation and maintenance in a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will ... utilities, and facility qualification, process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …/systems SMEs to define reporting needs to oversee process performanceShare and review data /metrics with the GRA Analytics TeamCoordinate the development and ... processes globally. This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this… more
- BioAgilytix (Durham, NC)
- …and manage studies in LIMS; maintain accurate laboratory records, worksheets, and raw data with peer review .Train, mentor, and direct junior scientists and ... budget, and revenue management.Act as primary client contact, presenting data , ensuring clear communication, and aligning project deliverables with client… more
- Merck & Co. (South San Francisco, CA)
- …positive change. -Experience with regulatory submissions and understanding of the review process. -Familiarity with cloud-based data platforms and technologies ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews overall processes and identifies areas of concern, arranges for remediation. Performs review of data entry convention documents, PVA reviews and SAE flow ... project. This position prepares trainings, supports CAPA investigations, case review , documentation reviews in collaboration with the ICSR management...plan / data management plan reviews. Works with ICSR management and… more
- Genmab (NJ)
- …and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review , and approval of data packages for Data ... discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information… more
- Merck & Co. (Rahway, NJ)
- …concepts, tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations) Review and approval of data and technical documentsAbility to ... and other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Exposure to project /… more
- Merck & Co. (North Wales, PA)
- …clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in ... Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing ... strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide… more
- Merck & Co. (Rahway, NJ)
- …scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in ... Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data … more
- Merck & Co. (North Wales, PA)
- …knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and ... of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination, Statistical Programming, Research Laboratories scientists and Regulatory… more
- Merck & Co. (Rahway, NJ)
- …Late Development Statistics. --Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other company Research Laboratories Scientists in ... the clinical trial planning, execution, and reporting.Develops individual protocols and data analysis plans and determines appropriate statistical methodology for … more
- Merck & Co. (North Wales, PA)
- …of drug therapy as outlined in the OR planning process and generates data on a worldwide basis to support pricing and reimbursement.Develops value evidence ... dossier, health economic evaluations) and their adaptation to generate country-specific data supporting pricing and reimbursement.Works closely with the VT team… more
- Genmab (NJ)
- …national, and global Medical Affairs strategiesProvide insights/feedback on emerging scientific/clinical data that enhance the value and appropriate use of Genmab ... all aspects of investigator sponsored trials (ISTs), from submission, review and approval, through study activation/completionCollaborate effectively and proactively… more
