- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work ... Clinical Operations Department that manages multiple early-late stage clinical programs. The Senior CPM will be...clinical trial management including execution of clinical trials from protocol finalization through closeout.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and ... of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program...execution of all operational components of a large-scale global clinical program using strong clinical project… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... the planning & successful delivery of studies within the clinical trial portfolio. Assists in creating, leading...external partners relevant to the design & implementation of clinical trials improvement/innovation projects for CDO &… more
- Merck & Co. (Rahway, NJ)
- …knowledge, statistical analysis and high-quality data to support decision making in clinical trials .Responsible for the development and execution of statistical ... development and safety evaluation.Collaborate with statistics and other project stakeholders in ensuring project plans are...with all of the following: SAS programming in a clinical trial environment including data steps, procedures,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to late-stage ... from forecasted spending and provide guidance to the internal project team(s) during the annual and quarterly forecast updates....to refine a financial model for all phases of clinical trials . Research and investigate key parameters… 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 ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.Analyzing and… 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 ... is essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial -related, GxP, Compliance, etc.) across the US and ... the strategy, development, effective execution of CMR role-specific/technical training (eg clinical trial -related, patient safety, therapeutic area leads, MSLs… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed drugs Planning clinical trials (design, operational plans, settings) based on these ... development strategies Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed drugs Analyzing and summarizing … 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
- Merck & Co. (Rahway, NJ)
- …and validation immunoassay-based assays that are deployed in support of clinical trials . The candidate for this Senior Scientist position should have strong ... and late-stage clinical development to execute on biomarker strategies in clinical trials .Writing memos, final reports and publications summarizing data, and… more
- Merck & Co. (North Wales, PA)
- …statistical analysis and high-quality data to support decision making in clinical trials .Support statistical programming activities for late-stage drug/vaccine ... and efficacy analysis datasets, tables, listings, figures), which range from individual clinical trials to worldwide regulatory application submissions and post… 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 ... other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of...trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles,… more
- Merck & Co. (Rahway, NJ)
- …new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the actual product Support 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
- Merck & Co. (South San Francisco, CA)
- …disease targets in discovery, being innovative and foreseeing the path to clinical trial .Leverage scRNASeq to contextualize target gene expression in the ... the Data, AI and Genome Sciences (DAGS) Department is recruiting a Sr . Principal Scientist, Computational Biology lead for Cardiometabolic Discovery Research.- We… more
