- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for ... relationship management, and budget planning.Extensive experience in directing large/ global clinical trials teams across different stages of study in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job Summary: Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities:Reconcile the TMF document trackers… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational...clin pharm patient studies , and Phases 1-3 clinical trials at the study and program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, ... Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads...with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... (Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for their assigned studies , which could vary in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... and operational plans associated with the downstream activities of clinical supplies for their assigned studies .- The...Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects.At the time of implementation of a CDx study /IVDR performance evaluation study integration of an assay into clinical testing (before testing) and ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have… more
- Eisai, Inc (NJ)
- …overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and ... is to lead collaboration efforts with RandD IT to implement and maintain Eisai's global (Veeva) eTMF system. To provide oversight and guidance to ensure the eTMF… more
- Genmab (NJ)
- …industry for Programming Manager, at least 6-8 years of experience for Senior Programming ManagerHas experience working in a global contextProficient in ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...in leading the programming efforts of at least one study are in scope.The Programming Manager will support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision… more
- Merck & Co. (Upper Gwynedd, PA)
- …and programsIn collaboration with internal teams and external partners, designs studies , authors study protocols, develops measurement questionnaires, case ... work.-Develops American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value DossiersDevelops supplementary clinical data package in close… more
- Merck & Co. (North Wales, PA)
- …and programsIn collaboration with internal teams and external partners, designs studies , authors study protocols, develops measurement questionnaires, case ... work.-Develops American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value DossiersDevelops supplementary clinical data package in close… more
- Merck & Co. (Rahway, NJ)
- …regions simultaneouslyReview and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before ... to Product Development Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to… more
- Merck & Co. (Boston, MA)
- …requirements and enables cross-Tumor Team execution and successful approval of the product.Ensures clinical programs and clinical studies are designed and ... .ADTs will be responsible for conducting or working with Translational Medicine to conduct clinical pharmacology studies (eg food effect, DDI, TQT, etc), as well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation of a quality strategy ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...with cross functional leadership team (ie, OBU, SBU) and study teams to uphold the ethical conduct of interventional,… more
- Merck & Co. (Lower Gwynedd, PA)
- …in a fast-paced regulated environment to contribute to the support of the vaccine clinical studies . The candidate will be able to leverage the understanding of ... immunology and analytical biochemistry to impact bioanalytical procedures supporting clinical studies .Responsibilities:Generation of quality experimental data to… more
- Novo Nordisk Inc. (San Mateo, CA)
- …NNI and competitor products Demonstrates thorough knowledge of all promoted NNI approved clinical studies and the skill to engage customers (prescribers, support ... offer the chance to be part of a truly global workplace, where passion and engagement are met with...access and drive business impact by collaborating around the clinical management of patients and offering NNI-approved solutions Demonstrates… more
- Beckman Coulter Diagnostics (Miami, FL)
- …with diagnostic tools that address the world's biggest health challenges. The Senior Clinical Research Associate for Beckman Coulter Diagnostics is responsible ... readiness and preparation.Support the in-house biorepository by receiving, shipping, and tracking clinical study samples.May perform other clinical project… more
