- Eisai, Inc (Nutley, NJ)
- …from you.Application Programmer sought by pharmaceutical company in Nutley, NJ.Support clinical applications for clinical data management. Perform ... tools and other utilities. Support different types of external clinical data transfers eg, laboratory data...been gained concurrently): Working in Windows and UNIX environment; Data processing and reporting tools: Microsoft Project ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …/ Continuous Improvement:Provides comprehensive data management expertise to project /study teams to optimize study-specific clinical trial processes.May ... change management, and risk management. Responsibilities Leadership, Direction, and Strategy:Establishes Data Management strategy at the project and/or study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …continuous improvement opportunities.Communicate and reinforce content and interpretation of Daiichi Sankyo's Clinical Data Standards to DS Project and Study ... in a pharmaceutical , biotech company, or similar environment with extensive Clinical Data Management (CDM) and Standards experience, hands-on experiences in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data ... More Years Experience with a Bachelor's Degree in the pharmaceutical industry and in the area of clinical...of key global laws, regulations and guidelines relating to clinical trial documents and data disclosure is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project ;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other… more
- Insmed Incorporated (Bridgewater, NJ)
- …specialization in Dermatology is a plus.A minimum of 5+ years of clinical development experience in the pharmaceutical /biotech Industry. Previous experience ... EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data ...knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… more
- Merck & Co. (Rahway, NJ)
- …comprising of Process Research & Development, Analytical Research & Development, and Pharmaceutical Sciences & Clinical Supply. The ideal candidate should have ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the… more
- Insmed Incorporated (Bridgewater, NJ)
- …designing clinical pharmacology programs and studies, performing PK and PKPD data analysis, supporting clinical dose selection and authoring summary and ... of abstracts and manuscripts for publicationClosely partner with Research, Clinical teams, Bioanalytics, Regulatory, Project Management, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Strategy:Provides data management (DM) expertise and guidance to the project team regarding the data management DM activities and deliverablesEstablishes ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address... Data Management strategy at the project and/or study level for a larger number of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... from the world's biomedical literature in support of regulatory, clinical research, marketing, and legal functions.- Plans, organizes, monitors, coordinates,… more
- Atlas Data Systems (Boston, MA)
- …area of Computer Science, Data Science Strong and Relevant Clinical Data experience 10+ years of Project Management experience is required EST required. ... Work you will do: We are seeking a Project Manager to support our pharmaceutical ...etc. Job Requirements Qualifications & Experience: Proven experience with Clinical Data , Modeling, and Simulation domains. A… more
- Eisai, Inc (Nutley, NJ)
- … trial setting and observational studies.Serve as the lead statistician on project teams, offer statistical insights into clinical development plans, review ... responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all programming ... data review listings and reports to support Data Management and clinical teams.Develop, implement and...6 years (w/BS) or 4 years (MS) SAS and clinical programming experience in the biotech/ pharmaceutical /CRO industry… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SDTM and industry standard data collection practices. Clinical data management experience in a medical device, pharmaceutical company, or similar ... External Data Management, is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams,… more
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