- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as a Clinical Trial Manager Experience with global clinical trial operations, in multiple phases of research Strong knowledge of ICH guidelines, GCP ... The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a...Senior CPM will be responsible for all aspects of clinical trial management including execution of … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as a Clinical Trial Manager Experience with global clinical trial operations, in multiple phases of research Strong knowledge of ICH guidelines, GCP ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are...Director role will be responsible for all aspects of clinical trial management and oversight of … 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)
- …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
- Genmab (Plainsboro, NJ)
- …as Clinical Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project / Trial ManagementObtain Project / ... new/additional scenarios) that may impact clinical drug supply)Create and maintain program/ project and trial IMP/AMP forecast and demand plans throughout the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio. Assists in creating, leading & delivering upon ... regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) Experience in managing/monitoring clinical research sites (in-house or on-site) prior onsite… more
- Merck & Co. (Rahway, NJ)
- …systems.Strong knowledge of GCP and GLP.Thorough understanding of clinical research and clinical trial methodologies.Strong regulatory knowledge, ... role involves close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... MS/MPH preferred4 or More Years with PharmD/PhD preferredExperience considered relevant includes clinical or basic research in a Pharmaceutical company, a… more
- Genmab (Plainsboro, NJ)
- …Planning and Operational ExecutionOversee strategic and operational plans for clinical trial drug supply.Maintain agreements, contracts, and SOPs ... demand, manage inventory, and prevent stockouts.Lead cross-functional collaborations, including Clinical Project Supply Team discussions.Change and Stakeholder… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strong understanding of market needs and resource allocation Strong expertise in clinical trial methodology and conduct, and GCP principles Superior ... within Novo Nordisk Inc. and Global HQ. Key internal relationships include Project Managers, Clinical Directors, Medical Affairs directors, HEOR Directors,… more
- Genmab (Plainsboro, NJ)
- …you will play a pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials. In addition, this ... others.You will join a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the Global Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process ... Experience Qualifications: 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requiredMaster's Degree preferred Experience: Minimum of 5 years of Global Clinical Trial experience in the device/pharmaceutical/CRO industry required.Expertise ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Job Summary: The Manager, Clinical Data Repository Administration is a member of 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 Experience… 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
- 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)
- …(phase I trials) o Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB), ... 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
- 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 CRO and ... other vendor performance against project goals and milestones to monitor and ensure compliance...with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical… more
