- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… 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
- 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)
- …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 (Plainsboro, 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
- Merck (West Point, PA)
- …chains. This role works closely with internal stakeholders in the GCS (Global Clinical Supply), GCTO (Global Clinical Trial Organization), procurement, and ... **Job Description** **Position Description:** ** Senior Specialist, Procurement, Global Clinical Supply**...stakeholders and suppliers in the context of a challenging clinical trial environment. + Interpersonal and communication… 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
- 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
- J&J Family of Companies (Raritan, NJ)
- …the appropriateness of conclusions. This includes providing market access inputs to clinical trial design, implementation, and analyses and knowledge of ... Senior Global Compound Market Access Leader, CVM&PH -...meta-analysis as well as epidemiologic studies. + Clinical Trial Methodology: Knowledge of … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely...compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity… 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
- Sumitomo Pharma (Trenton, NJ)
- …Quality Assurance and/or Quality Control function for marketed pharmaceutical products or clinical trial materials. Review regulatory IND, IMPD, CTD and BLA/NDA ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Associate Director ensures compliance… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …findings through presentations and/or publications in peer-reviewed scientific journals + Assess clinical trial and/or other data sources to contextualize safety ... around rare diseases and immune disorders. **SUMMARY** + The Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic… more
- Sanofi Group (Bridgewater, NJ)
- …submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation + Ensure that regulatory messaging for regulatory ... position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects +… more
- Sanofi Group (Bridgewater, NJ)
- …submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation + Ensure that regulatory messaging for regulatory ... position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects +… more
- J&J Family of Companies (Spring House, PA)
- …the clinical study of immunologic disease, immunologic pathways, and in early clinical trial design and execution. TS has expertise in biomarker development, ... (both in clinical development and translational science). Within TM, the Senior Director will be part of the leadership team with responsibility for creating… more
- Bristol Myers Squibb (Princeton, NJ)
- …team of outsourcing managers within a specific therapeutic area(s) and manages clinical trial vendor partnerships that supports alliance and outsourcing ... management across multiple service categories of clinical trial activities in R&D. **Key Responsibilities**...R&D. **Key Responsibilities** + Leads a team of Outsourcing Associate Directors and Managers within a specific TA, and… more
