- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... and consistent application of external data vendor access standards across DS clinical programs. Participate in the development of and ensure compliance to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …participating in regulatory agency inspections, partner audits, and QA inspections preferred- Clinical Data Repository system. Required Travel Ability to travel ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality and adherence to established coding conventions. In collaboration with the Study Data Manager , monitors coding metrics and trends on a scheduled basis ... strong working knowledge of medical terminology concepts and industry standards and technical skills in coding data ...MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience in… 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 ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... to experiment with us? The Position The HCP CX Manager -CV/Renal will be a critical driver in ensuring the...quality control of marketing content in alignment with compliance standards Continued Improvement: Ensure pull-through of 'test and learn'… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Laboratory Compliance Manager role is an exempt level position with responsibilities...the site Quality Control laboratories in support of both clinical and commercial manufacturing. This role will be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… 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...seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase...and investigate key parameters through quantitative analyses of historical data and assist in designing initiatives and development of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the site Quality Control laboratories responsible for testing of pre- clinical , clinical , and commercial stage CAR-T cellular therapy products. ... procedures (SOPs), validation/ qualification/ method transfer protocols, completed assay data and reports primarily for the quality control laboratories.Key… more
- Novo Nordisk Inc. (Sacramento, CA)
- …techniques Maintain up to date knowledge of the latest approved scientific and clinical data to engage in meaningful discussions with customers and address ... experience using sales data /call reporting software ideal Mastery knowledge of the clinical management of diabetes and the range of treatment options Must be a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and support documentation and records to certify compliance with in-house specifications/ standards and GMP for all NNUSBPI products. This position has QA ... Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Takeda Pharmaceuticals (Columbus, OH)
- …true to the best of my knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely and high ... of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides...They will lead cross-functional team members to perform proper Data Reviews, and provides guidance on CDISC standards… more
- Medtronic (Fridley, MN)
- …compassionate world. **A Day in the Life** In this exciting role as a Senior Clinical Data and Biostatistical Sciences Manager , you will be responsible for ... Change Lives** In this exciting role as a Senior Clinical Data and Biostatistical Sciences Manager...protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards . + Develops and/or… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Manager , Clinical Data Management Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical -stage biotechnology ... Position Summary: Reporting to the Executive Director, CDM, the Manager , CDM will be a highly motivated, quality-focused individual... clinical trial objectives and corporate goals. The Clinical Data Management (CDM) department plays an… more
- Takeda Pharmaceuticals (Columbus, OH)
- …functions: Clinical Data Management, Clinical Data Engineering, Clinical Data Standards , Clinical Trial Tools and Technologies, Risk ... empower you to shine? Join us as a Senior Manager , Integrated Clinical Trial Data ...of new processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs).… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12521BR** **Title:** Sr. Manager , Clinical Data Management **Job Description:** The Senior Manager , CDM oversees clinical data management ... ability to coach and mentor. 4. Knowledgeable in GCP standards , FDA and ICH guidelines, and recommended CDM Best...well as part of a team. **External-Facing Title:** Sr. Manager , Clinical Data Management **Posting… more
