- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from creation, study initiation, study conduct and oversight (study monitoring, tracking of clinical data), database lock, creating Clinical Study Report, ... diseases and immune disorders. Summary This position is a Clinical Science lead position and will lead a group...Science lead position and will lead a group of clinical scientists organized around one or more clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...leader and liaise with CRO to support interim analysis, database lock and review of TLG before and after… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... from the world's biomedical literature in support of regulatory, clinical research, marketing, and legal functions.- Plans, organizes, monitors, coordinates,… more
- Merck & Co. (North Wales, PA)
- …position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate ... with global, cross- functional team-members including clinical directors and study managers to lead/support ...set up and design during study start up (eg, database set up)Lead medical monitoring team in review and… more
- Insmed Incorporated (San Diego, CA)
- …effective scientific and administrative operations. Operates, maintains, and repairs clinical laboratory equipment within scope of training including routine ... and reviews area weekly and monthly Quality Control and maintain QC database . Set up and validate new assays as assigned by the manager.ResponsibilitiesManage… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Job Title:Head of Clinical Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager's Job Title:Head of BDMDepartment ... responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Merck & Co. (North Wales, PA)
- …for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and our company's ... Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- …cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiac, respiratory, metabolic, ... Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- …in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.Associate Directors are emerging leaders in the field of quantitative drug… more
- Catalent (Philadelphia, PA)
- …Supervisor. The Pre-Distribution Supervisor is responsible for distribution supervision of clinical supplies . This is a full-time position: Monday - Friday, ... located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical … more
- Merck & Co. (Rahway, NJ)
- …team in the role of Director. QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Support statistical programming activities for clinical development projects.This may include leadership of one or more ... execute statistical study and report deliverables ranging from individual clinical trials to world-wide regulatory application submissions.Design and maintain… more
- Merck & Co. (Rahway, NJ)
- …continuity.The FLEx sterile area supports the formulation and filling of clinical , stability, and developmental supplies for biologics and vaccines, including ... as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development… more
- Catalent (Emeryville, CA)
- …and Catalent's novel conjugation chemistry and proprietary, stable linkers. SMARTag is a clinical -stage technology that was named Runner Up for Best Platform at the ... are a research site, working to develop therapeutic ADC drug candidates for clinical testing. We also continuously strive to improve and expand our technology… more
- Merck & Co. (Rahway, NJ)
- …PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs ... approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming critical drug development questions for… more
- Merck & Co. (Rahway, NJ)
- …pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA) and clinical trial simulations (CTS) into programs and thereby strengthening ... quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsServe as a subject matter expert… more
- Aequor (New York, NY)
- Position Purpose:Provide case management and clinical services to employees within their regulated scope of practice.Experience/Education: BA/BS in nursing degree ... disease prevention programs Documents patient data in electronic medical database (s), as per standard protocolsTechnical Competency Description: Health Insurance… more
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