- Merck & Co. (Rahway, NJ)
- …role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, ... Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to… more
- Novo Nordisk Inc. (Los Angeles, CA)
- … 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. (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, ... 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. (Rahway, NJ)
- …clinical research experience. Related CR experience may include Clinical Trial -Assistant, Study Coordinator, Regulatory CTC or ... and ensures continuity of site relationships through all-phases of the trial .Performs clinical study site management/monitoring activities in compliance with… 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 research vendors). Manages relationships… 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)
- …stakeholders including the Global Project Manager, Alliance Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team, Outsourced Trial ... and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data ... employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the...or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab… 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
- 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
- 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
- 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
- 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
- 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
