- 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 research vendors). Manages relationships… more
- Novo Nordisk Inc. (Phoenix, AZ)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with… more
- Merck & Co. (Rahway, NJ)
- … Research Director) as needed.Works in partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate ) and/or CRA Manager,...clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC… more
- Merck & Co. (Rahway, NJ)
- …Research Director) as needed.-Works in partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory ... Job DescriptionWith support of Sr CRA ( Clinical Research Associate ) and/or CRA Manager,...Related CR ( Clinical Research) experience may include Clinical Trial -Assistant, Study Coordinator, Regulatory CTC (… more
- Merck & Co. (Rahway, NJ)
- …The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). Contribute to the development and/ or… 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, ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for… more
- Merck & Co. (North Wales, PA)
- …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … 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)
- …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)
- …or related field plus 9-12 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... field plus 7 or more years SAS programming experience in a clinical trial environment.Required Experience and Skills:Excellent interpersonal skills and ability… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will ... and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who… 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
- 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)
- …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. (Boston, MA)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational Medicine, will be responsible for leading the Translational… more
- Merck & Co. (Rahway, NJ)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Job DescriptionThe Associate Vice President (AVP) will be responsible for...strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the… 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 ... our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming… more
- Catalent (San Diego, CA)
- …performance of production audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs.Other duties as assignedThe Candidate: ... Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… 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...the knowledge gaps (for example: New TA knowledge, New Trial /Protocol etc.) Collaborate with Subject Matter Experts to ensure… more
