- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications 7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or Pharmaceutical ... management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The...Logistics (SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... primary source of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking ... 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people ... 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg, CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management . required- 4+ years combined ... and laboratory data expertise to promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to ensure all laboratory data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the safety risk assigned remains top of mind in the context of patient management in the clinical trial setting and in the real-world setting.Contributes ... CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clinical development in the pharmaceutical industry with involvement in regulated clinical trial and / or technical QA activities (ie, eClincial, Data ... development systems, PV systems and MA systems including data management , statistical programming, digital technologies, and clinical operations.Design and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs… more
