- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in collaboration with the CRO and the study team. Oversee the site qualification process. Monitor clinical trial performance and quality metrics and share ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...assess potential risks to the study and propose mitigation plans. Monitor study budget against trial progress and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in collaboration with the CRO and the study team. Oversee the site qualification process. Monitor clinical trial performance and quality metrics and share ... and reporting.Proactively assess potential risks to the study and propose mitigation plans. Monitor study budget against trial progress and bring deviations to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... sections of submission documents under guidance of CSL and/or Medical Monitor . Represents Clinical Development on Study Team and collaborates as team member with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...to process standards and tools to achieve excellence in trial operations and management. Monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Execution: As CSL for Phase 2 Studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lessons learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:- monitor GCO processes ... expertise and trending to shape the future of Daiichi Sankyo clinical trials .Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of those principles to trial design, planning & conduct of clinical trials Deep understanding of Distributor, Logistics and Demand Planning Operations, ... This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply...external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective Serves as a primary ... source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... employer including veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required- 3+ Years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development… more
- Catalent (Philadelphia, PA)
- …and interpretation of regulations/guidelines related to GXPs focused mainly on good clinical trials , as applicable. Writes and approves Quality unit SOPs ... Philadelphia, PAPosition Summary: The Quality function is to build, monitor , and sustain a robust and effective quality system...15 + years of Scientific or Quality Assurance in clinical trials packaging, in addition of commercial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials ; Reviews regulatory documents from cross functional, holistic ... and participate in regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project; Attends EOP2 meeting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... controls in relevant process steps to ensure adherence to regulatory compliance. Monitor effectiveness of implementation of applicable clinical development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that Payer and KOL reimbursement requirements for key markets are included in the clinical trial / evidence generation plans- Act as an ambassador to drive ... key planning processes for Brand planning and portfolio review- Provides input to Clinical on trial design, endpoints and comparators to support optimal price,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and globally, and provide legal support for licensing, co-promotion, co-development, clinical trial collaboration, co-marketing and acquisition agreements (among ... in negotiating, drafting and reviewing licensing, co-promotion, co-development, co-marketing, clinical trial collaboration, companion diagnostic, and acquisition… more
- Insmed Incorporated (Bridgewater, NJ)
- …assays (eg M10 Bioanalytical Method Validation).Familiarity and experience in establishing clinical biomarker analyses for clinical trials .Strong ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Catalent (St. Petersburg, FL)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... Master Shipper Labels, Process recipes, various technical protocols (Pre-Commercial Clinical Packaging Protocols, Process assessment, Method Validation, Bulk Mfg… more
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