- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in… more
- Novo Nordisk Inc. (WA)
- …and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with ... The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing;...(NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or… more
- Novo Nordisk Inc. (Irvine, CA)
- …and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with ... The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing;...(NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label Development process ... preferredExperience Qualifications7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative research studies ... the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good … 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 ... Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Job DescriptionOur Research Scientists are our Inventors. We identify and...and USP .Experience in representing analytical functional area on project teams.-Experience with complex glycan analysis and link to… more
- Merck & Co. (North Wales, PA)
- …Experience and Skills:Minimum of 8+ years' experience in Ophthalmology clinical research . Prior industry experience strongly preferred.Substantial experience ... directors responsible for clinical programs.Supervises development of clinical documents including development plans, protocols, trial related documents,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for… more
- Merck & Co. (North Wales, PA)
- … research activities for innovative statistical methods and applications in clinical trial development.Mentors and guides junior staff in functional ... processing software eg SAS and/or R.-Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Strong oral and… more
- Merck & Co. (North Wales, PA)
- …of the study protocol.Prepares oral presentations and written reports to effectively communicate clinical trial results to the project . team, company ... activities for innovative statistical methods and applications in clinical trial development.Education Minimum Requirement: PhD in statistics/biostatisticsOr… more
- Merck & Co. (North Wales, PA)
- …in a team environment - - Preferred skills : - Understanding of the principles of clinical research , clinical trial design , fundamental statistics, and ... : - Authoring accurate , clear and health literate clinical trial PLS for posting on EU...public facing materials, PLS , or other health literate clinical research materials - Experience communicating medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …In addition, he or she will interact with the Companion Diagnostics Lead, Non- Clinical Research , Medical Affairs and other stakeholders to support the program. ... in the US and Japan (eg other translational strategy leads, non- clinical research , translational biomarkers, companion diagnostics, bioinformatics, clinical… more
- Merck & Co. (North Wales, PA)
- …or related field and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life ... or related field and at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal skills and ability to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …models to aid in target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he will develop a QSP ... target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designDevelop and rigorously assess the functionality,… more
- Merck & Co. (Rahway, NJ)
- …Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisionsCollaborate with other functional areas,… more
- Merck & Co. (North Wales, PA)
- …with a minimum of five (5) years SAS programming experience in a clinical trial environment.Required Experience and Skills: Experience with study data standards ... external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting … more
