- Merck & Co. (Rahway, NJ)
- …to patients. The key areas of focus include: (1) diversity in clinical trials , (2) clinical trial recruitment and (3) general education and awareness ... globe, timely completion of carefully designed clinical trials is critical to drug development.The Associate ... trials communications strategy which includes the following:Amplify clinical trial key messages by managing the… more
- Novo Nordisk Inc. (Stamford, CT)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assigned clinical trials , document management and management of clinical trial management systems and archiving systems. Relationships Reports to a ... trials , including distribution of SUSARs to clinical trial sites Maintenance of systems, eg,...principles to trial planning and conduct of clinical trials Demonstrated computer skills (MS Office… more
- Merck & Co. (Rahway, NJ)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Merck & Co. (Rahway, NJ)
- …of flow cytometric assays that are deployed in support of clinical trials . The candidate for this Associate Principal Scientist position should have strong ... implementation of these assays and execute on biomarker strategies in clinical trials across early and late-stage clinical development.Liaise with external… more
- Tris Pharma (Monmouth Junction, NJ)
- … outcome measures, data review and support all appropriate manner of clinical trial activities. The incumbent primarily provides scientific, operational and ... teams to mitigate issues in initiation and management of one or more clinical trials and monitor guidelines, IDMS charter, statistical analysis plans, data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and the application of those principles to trial planning and conduct of clinical trials Demonstrated computer skills (MS Office, clinical trial ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck & Co. (Rahway, NJ)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...plus minimum 7 years SAS programming experience in a clinical trial environmentExperience leading large and/or complex… more
- Merck & Co. (Rahway, NJ)
- …more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials , clinical trial design and Go/No Go decisionsFraming critical ... (popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and trending to shape the future of Daiichi Sankyo clinical trials .Responsibilities- Process Improvement, Innovation and Optimization (IO):Project ... Support the build of industry expertise in innovation and optimization for clinical trials . Utilize strategic conferences for information mining and networking,… more
- Merck & Co. (Rahway, NJ)
- …and data analysis. You would also contribute towards regulatory submissions to enable clinical trials . Your main responsibilities, which are in no particular ... DescriptionAssociate Principal Scientist, Small Molecule Research & DevelopmentIn your role as Associate Principal Scientist, you will be part of a team developing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …space: site contracts, budgets, site payment and related reporting including global clinical trial financial transparency and Medicare, Medicaid, and SCHIP ... of financial transfers and payments in the conduct of clinical trials in accordance with applicable laws...process improvement initiatives for the global reporting of GCO clinical trial spend. Financial Transparency (FT) and… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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, ... disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred- 7 or More Years proven… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a ... target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials ) required- 7 or More Years Deep experience in pharma ... & category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated ability to leverage digital data… more
