- Novo Nordisk Inc. (Phoenix, AZ)
- …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)
- … quality systems and management of regulatory inspections.Knowledge and background in clinical development programs, clinical trial processes as well as ... The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively… 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, ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… 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)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… 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
- 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
- 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
- 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. (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 ... 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
- 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
- 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)
- …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
- Insmed Incorporated (Bridgewater, NJ)
- … Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the protocol ... understanding of advanced statistical concepts and techniques applicable to Clinical ResearchExcellent project management , interpersonal and communication… more
- TRIMEDX (Boston, MA)
- …and supporting each other Associates look forward to coming to work each day Every associate matters and makes a differenceIt is truly a culture like no other - We ... may serve as technical advisor to the medical and clinical staff in the safe operation and use of...nomenclature, and service history Adheres to the Medical Equipment Management Plan (MEMP), including all regulatory agency compliances and… more
