- Insmed Incorporated (Bridgewater, NJ)
- …and collecting TMF status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and ... review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms.Assists with… 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...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… 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 CRO and ... 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)
- …deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will ... US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance...Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …business, and other functional groups across NN. External relationships can include clinical trial sites and external vendors. Essential Functions Develop and ... escalating quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP...or resolve, for example across various topics, such as clinical trial management, deviation handling, and product… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant...clear direction on Medical Affiars engagement needs to the clinical data science & evidence team and other relevant… more
- WuXi AppTec (Cranbury, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... specified by project manager or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II personnel. + Participates in… more
- J&J Family of Companies (Raritan, NJ)
- …provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and clinical ... will collaborate with Study Responsible Physician(s) in monitoring of clinical trial conduct. This role involves extensive...and written results of product research, in concert with senior clinical personnel, in preparation for health… 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...vendors / ARO + Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… 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.../ vendors / ARO **Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …and/or pharmacologic) studies as per clinical strategy; Reviews, edits and finalizes clinical trial plans + Responsible for the relevance and accuracy of ... Peripheral Nervous System, Neuromuscular and Muscular Diseases. **As a Senior Medical Director, a typical day may include the...academic clinical trials (10 years post fellowship clinical and research experience, associate or full… more
- AbbVie (Madison, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager, Clinical Data and Reporting Standards (CDARS) proactively ... and reporting standards in support of AbbVie's portfolio of clinical trials and ensuring AbbVie's conformance to CDISC standards...governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment… 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 CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Pfizer (New York, NY)
- …transformation, analysis, and reporting + Supports the development, maintenance and analysis of clinical trial cost and resource metrics to increase accuracy in ... development process portfolio management and resource planning + Familiarity with Clinical Trial execution, Regulatory and/or Safety organizations Location:… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …studies/programs. This individual will monitor clinical studies, review and interpret clinical trial data, provide input into clinical study and ... respect in all we do, create and deliver. The Associate Director/Director Clinical Development, will be responsible... clinical development aspects of a project and clinical trial results at internal or external… more
- Bristol Myers Squibb (Summit, NJ)
- …Heart Failure, Thrombosis, and Lung Fibrosis. This group integrates laboratory science, clinical trial biomarkers, and asset development as well as disease ... stage drug development + Experience in activities required for and related to clinical trial initiation, maintenance and completion + Experience in interacting… more
- Merck (Rahway, NJ)
- …Operations Managers (CQOMs), GDMS, BARDS Statisticians and rest of members of the Clinical Trial Teams (including Country roles) to ensure that systems and ... of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the integration between our... quality framework. + Profound knowledge and understanding of clinical development programs, clinical trial … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and company policies. Drawing on disease state expertise and product knowledge, the Associate Director will support the Senior Director, Medical Affairs in ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.… more
- Merck (Rahway, NJ)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... **Job Description** The Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational...strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development. The AVP provides strategic oversight for the… more
