- Insmed Incorporated (San Diego, CA)
- …plans Contribute to scientific and operational aspects and stages of the protocol development and study execution, from study design planning through final reporting ... and materials for meetings as it related to the protocol (s) and program Provide protocol level scientific review of information to support the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure cross functional integration and delivery of study milestones (eg protocol , eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.)-Ensure operational study-level ... delegate certain responsibilities to Study Manager(s) assigned to the study- Protocol Development, and Team Assembly-Contribute to and interface with different… more
- Formation Bio (New York, NY)
- …lead the development of the Clinical Development Strategy and Plans, including protocol development, for clinical studies. As part of this responsibility you will ... doing drug development.ResponsibilitiesClinical Study Planning and Execution: Development of protocol concepts, protocols and clinical development plans Medical leadership… more
- Merck & Co. (Rahway, NJ)
- …output(s) and lead associated combination product design verification plan, protocol (s), and report(s) that demonstrate design output(s) meet design input(s).Lead ... design verification programs and leading activities (eg, strategy/ plan, protocol (s), report(s), test method development/validation, etc.) requiring cross-disciplinary project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Study Associate Manager within Clinical Operations, in adherence to the protocol , Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), ... and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.Compile… more
- Genmab (NJ)
- …member:Participate and represent BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable ... SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.Review assay… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of any gaps and processes not being followedProvide support in the protocol review committeeQualifications: Basic understanding of FDA, ICH regulations, Interest in ... learning about health authority regulations and compliance. Knowledge about writing processes and procedures. Basic understanding of clinical trial development and operations Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. All… more
- Merck & Co. (San Francisco, CA)
- …our medicines.The Senior Principal Scientist has primary responsibility for protocol development and medical/scientific oversight of clinical research studies ... involving investigational or marketed drugs in the HIV section of the infectious diseases therapeutic area.- The individual will participate in all phases of clinical trial process (mainly Phase 2-3) including study design, medical monitoring, and… more
- Merck & Co. (Durham, NC)
- …Support work as needed to implement improvements (eg scheduling, staffing, protocol execution)- Coach team members in executing smaller improvement projects in ... their operational area- Represent Operations on project teams as needed- - Communication- Lead and support daily (Tier) meetings to facilitate flow of information up/down through the organization- Hold regular team meetings to cascade information and collect… more
- Merck & Co. (North Wales, PA)
- …strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive ... intelligence.- The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the… more
