- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations . This position develops ... SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews ...with CROs to execute study start up processes.ResponsibilitiesGlobal PV Operations Representation on Clinical Study Teams: Represents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing data collection, data ... management activities by acting as a liaison for CDx Operations , Data Management, CROs and oversee the...data collection practices required- 4 or more years Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... Job Summary The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Merck & Co. (Rahway, NJ)
- …company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes for diverse ... biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and the development and… more
- Merck & Co. (New York, NY)
- …and retention efforts to achieve study milestones.Upon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential ... applicable policies.Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the… more
- Merck & Co. (Rahway, NJ)
- …experience partnering for Pharmaceutical development / CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional areasExperience ... and regulatory filings. The successful candidate will be key in implementing strategy , conducting scientific research from the laboratory to commercial scale, step… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... for next-generation biologic manufacturing processes.Apply rigorous scientific principles and data analyses to solve challenging problems related to developing… more
- AbbVie (Jersey City, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Clinical Data Strategy & Operations is the best-in-class team within its ... process, and technology together to generate business value from clinical trials data . Our operational model is...in oversight of vendors and provides feedback related to clinical trial operations , issues, and trends in… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Abbvie Clinical Data Strategy and Operations (CDSO) is best in class team ... is exemplified through execution and innovation. The Director of Clinical Data Strategy & Operations (CDSO) oversees the Oncology therapeutic area . This… more
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Clinical Data Strategy and Operations (CDSO) is the best-in-class team ... process, and technology together to generate business value from clinical trials data . Our operational model is exemplified through execution and innovation.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …to clinical trial management, vendor management, shared services, and clinical operations + Demonstrated leadership experience in a management position ... in Armonk, NY or Basking Ridge, NJ._ The Director, Strategy Planning & Operations will partner with...is well-aligned cross functionally, internal and external to Development Operations , Portfolio Management, and Biostatistics & Data … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global ... mitigation plans + Required to inform and shape clinical laboratory operations goals, including progress, schedules of testing/ data generation across the… more
- IQVIA (Parsippany, NJ)
- **Role Summary:** The Health Data Associate Product & Strategy Director is responsible for sourcing and leveraging health data for the benefit of the Digital ... met and that the product/s support the company's overall strategy and goals. + Assess and understand the market,...analysis. + Evangelize and educate staff on available health data . **Product Operations ** + Define and prioritize… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets ... management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership...Final Protocol + Review of plans and provision of clinical operations expertise during protocol design, feasibility,… more
- Touro University (New York, NY)
- …an accomplished IT professional, you will join our organization as a Director of Clinical IT Operations . This role requires an individual with strong technical ... system wide leaders and technical engineers, execute a comprehensive strategic plan for clinical IT operations that supports the University System's mission and… more
