- Novo Nordisk Inc. (Plainsboro, NJ)
- …development experience in the pharmaceutical industry At least 3-5 years of experience as a Clinical Trial Manager Experience with global clinical ... The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a...clinical trial management including execution of clinical trials from protocol finalization through closeout.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… 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 ... areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and… more
- Genmab (Plainsboro, NJ)
- … Clinical Drug Supply Manager , of the following tasks:Global Clinical Drug Supply Project/ Trial ManagementObtain Project/ Trial specific information to ... is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our...team focused on planning and maintenance of supplies for clinical trials , working closely with the Global… more
- Genmab (Plainsboro, NJ)
- …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 position ... purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our...highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the pharmaceutical industry with management experience At least 5 years of experience as a Clinical Trial Manager Experience with global clinical ... Director role will be responsible for all aspects of clinical trial management and oversight of ...vendor management Experience in rare disease, pediatric, and/or complex clinical trials preferred Ability to deal with… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery ... trial specific Clinical Trial Teams (CTT) to deliver clinical trials including managing the trial budget. The GCTM is accountable for trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project, MS ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… 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 ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... (phase I trials ) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in clinical trial outsourcing, health sciences or related field ( clinical trials ) required- Advanced WORD and Excel skills preferred- Excellent time ... the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional...management skills preferred- Experience with PH.1 - PH.IV clinical trial vendor contracts required- Experience with… 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 ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...to PDPs from NNI PDP Forum Partner with Project Manager to track workstreams under the Project Teams Provide… more
- Genmab (Plainsboro, NJ)
- …for coordinating sourcing for new trials to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act ... as well as coordinate and manage outsourcing of new trials . The role will include responsibilities in - and...communication and resolve issues.Vendor Owner:First Point of Contact for clinical trial vendors: Serves as the first… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or similar environment (eg, CRO) requiredOncology, immunology, or complex disease clinical trial experience preferredMust have a strong understanding and ... around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical...MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials , and regulatory requirements. TravelAbility to travel up to 5% ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Develop and continue to refine a financial model for all phases of clinical trials . Research and investigate key parameters through quantitative analyses of ... - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase...Budget templates in support of early phase to late-stage clinical studies. Accountable for the control and reporting of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role… more
