- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary Job Summary The Clinical Trial Assistant will support all phases of clinical study activities ... clinical trials. Oversees and resolves operational aspects of clinical trials in conjunction with project teams...country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures study is conducted… more
- Novo Nordisk Inc. (Los Angeles, 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
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to: Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using ... Preferred Experience and Skills: Drug discovery experience, including familiarity with clinical trial execution in Oncology studies. Biomarker assay experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical studies, knowledge of drug development phases, statistical research methodology experience) Leadership skills; project management skills; effective ... in the assigned therapeutic area. Relationships Reports to the Executive Director- Clinical Research & Development. Internal relationships include working with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label… 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
- Merck & Co. (Rahway, NJ)
- …the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the ... manage scientific activities on clinical protocols.Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple… more
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to: Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using ... Experience and Skills: Drug discovery experience, including familiarity with clinical trial execution in Oncology studiesBiomarker assay experience… 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. ResponsibilitiesStudy Strategy:...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
- 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 DescriptionThe Small Molecule Analytical Research and Development (SMAR&D) group has an exciting...methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product… more
- Merck & Co. (Rahway, NJ)
- …optimal trial design and monitoring of studies, producing high-quality clinical documents and presentations. The position requires a solid understanding of the ... input into research and business development priorities and prioritization of clinical assetsMay serve as the senior liaison for relevant stakeholders in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations ... Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources...PharmD required A minimum of 5 years of combined clinical , research or Pharma experience required 5… 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
- 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 ... facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future,… 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 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.MS (preferred) in Computer Science, Statistics, Applied ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required-Experience and Skills: Proven track record for… more
- Merck & Co. (North Wales, PA)
- …field plus 9 or more years of SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, ... Job DescriptionI n BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...or more years of SAS programming experience in a clinical trial environmentDepartment Required Skills and Experience:Excellent… 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
- Merck & Co. (Rahway, NJ)
- …in developing analysis and reporting deliverables for clinical trial projects (data, analyses, tables, graphics, listings)Strong project management ... or related field plus 9 years SAS/R programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life… more
