- 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)
- …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
- 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
- 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
- Merck (Trenton, NJ)
- …The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed ... Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT). + Collectively and periodically (eg quarterly)… 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
- 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
- Amicus Therapeutics (Princeton, NJ)
- Associate Director, Clinical Data Management Location Princeton, NJ Requisition ID 2245 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1289) Associate Director, Clinical Data Management Amicus Therapeutics is… 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
- Bristol Myers Squibb (Trenton, NJ)
- … Trial /Site Identification & Support_** + Tracks FM region activity toward clinical trial visits/ISR management, as appropriate + Ensures that the role ... RD position is also responsible for working closely with senior management to create and execute medical initiatives at...Ensures active participation of FM in providing input on clinical trial site selection and feasibility based… more
- Bristol Myers Squibb (Princeton, 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
- Bristol Myers Squibb (Princeton, NJ)
- …management within a specific therapeutic area(s) and is accountable to manage clinical trial vendor partnerships that supports alliance and outsourcing ... management across multiple service categories of clinical trial activities in R&D. Key Responsibilities + Serve as primary or escalation trial -level point of… 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
