- Novo Nordisk Inc. (San Antonio, TX)
- …goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects ... and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with multiple… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects ... trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, IRBs, clinical research vendors). Manages relationships with… more
- Merck & Co. (Rahway, NJ)
- …The key areas of focus include: (1) diversity in clinical trials, (2) clinical trial recruitment and (3) general education and awareness of clinical trials. This job ... of carefully designed clinical trials is critical to drug development.The Associate Director, Clinical Trials Communications role within our Research & Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on demand planning, supply planning, and distribution requirements planning and Trial deliverables across NACD. This includes leading processes and technology ... improvements to link Clinical trial site needs, Finance and Supply forecasts that will...and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior… more
- Merck & Co. (North Wales, PA)
- …including clinical directors and study managers to lead/support-clinical trial scientific activities.Job Responsibilities Responsible for the clinical/scientific ... clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at ouor company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and thereby… more
- Merck & Co. (North Wales, PA)
- …Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, Statistical ... management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills. Able to… more
- Merck & Co. (North Wales, PA)
- …to discover the next medical breakthrough.Position Description: The Associate Principal Scientist Statistical Programming leads the statistical programming ... years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in Computer Science, Statistics, Applied Mathematics,… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research ... facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked...release, characterization, and stability assays for testing of clinical trial material and in support of product and process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end ... accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative ... include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a QSP strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to close the knowledge gaps (for example: New TA knowledge, New Trial /Protocol etc.) Collaborate with Subject Matter Experts to ensure that training ... preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, Training &… more
- Merck & Co. (Rahway, NJ)
- …ensures continuity of site relationships through all phases of the trial .Performs clinical study site management/monitoring activities in compliance with ICH-GCP, ... Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.Gains an in-depth understanding of the study protocol and related procedures.Coordinates & manages various tasks in collaboration with other sponsor roles to… more
- Catalent (San Diego, CA)
- Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Quality Assurance (MQA) Associate II ... of line clearances in a Class 100,000 environment, maintenance of clinical trial material inventory logs;Duties include but not limited to hosting client and… more
- Catalent (San Diego, CA)
- Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing ... group. A QA Associate I must be familiar with applicable GMPs. This...audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs.Other duties as assignedThe Candidate: High… more
- Merck & Co. (North Wales, PA)
- …field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and ... with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and comparators to support optimal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic ... through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize safety events for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros or tools to ... effectively support all programming needs. Responsibilities include: identify the macros or tools that will facilitate programing efficiency, lead the macro or tool development by working with contractors or by self, and support the macro or tool… more
