- Novo Nordisk Inc. (San Antonio, TX)
- …proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and ... 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)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, IRBs, clinical...minimum of 2 years of direct expertise of site management and logistical execution of clinical trials… more
- Merck & Co. (Rahway, NJ)
- …a fast-paced matrixed environment. Preferred Experience & Skills: Clinical trial communications experience Budget and agency management experience. NOTICE ... The key areas of focus include: (1) diversity in clinical trials, (2) clinical trial ...stage around the globe, timely completion of carefully designed clinical trials is critical to drug development.The Associate… more
- Merck & Co. (North Wales, PA)
- …team members including clinical directors and study managers to lead/support- clinical trial scientific activities.Job Responsibilities Responsible for the ... clinical /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills. Able… 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 ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immunology, or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus preferred ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who ... deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will… 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 ... International Conference on Harmonization (ICH) guidelines and regulatory requirements for clinical trial managementWorking knowledge of Electronic Data Capture… more
- Merck & Co. (North Wales, PA)
- …on a global basis. We are responsible for negotiating industry sponsored clinical trial agreements, confidentiality agreements, and other type of agreements ... implementation of COA measures in connection with our company clinical trials through strong project management and...of relevant experience in the pharmaceutical industry or an Associate 's Degree with a minimum of 5 years of… more
- Merck & Co. (Rahway, NJ)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming… more
- Merck & Co. (North Wales, PA)
- …of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in Computer Science, Statistics, Applied ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required Experience and Skills: Experience leading large… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...to Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to meet ... immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Merck & Co. (North Wales, PA)
- …or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... related field plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize ... areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic… 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 ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is preferred A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge… more
