- Daiichi Sankyo, Inc. (Bernards, NJ)
- … flow, pharmacovigilance, and biostatisticsKnowledge of industry standards and best practices in clinical data management and relevant Good Clinical ... management , coaching and development of team members.Acts as a Data Management point of contact for Senior Management and high-level internal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...teams, leading research projects, coordinating/managing research vendors, & budget management . RelationshipsThe fellow will report to the Senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from end to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement ... function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior...several programs. Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management , and Non- clinical Development. Essential Functions ... clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer...in the department General Tasks: Interprets and accurately presents clinical and statistical data in a clear,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Senior Translational Strategy Lead.Construct translational plan documents, biomarker data analysis plans, and aid in the construction of clinical ... enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing so, he or… more
- Merck & Co. (North Wales, PA)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management , and ... leadership in design and analysis of clinical trialsStrong project management skills. --Solid knowledge of- statistical and data processing software… more
- Merck & Co. (Rahway, NJ)
- …and other Research Laboratories scientists in analyzing oncology biomarker and clinical data .-Primary activities:Serves as the lead statistician to support ... scientific statistical analysis plans for oncology biomarker projects.Analyzes biomarker and clinical data and interprets the results.Prepares oral presentations… more
- Merck & Co. (North Wales, PA)
- …to be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... stakeholders.Position Specific Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Eisai, Inc (Nutley, NJ)
- …is driven to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific ... across all phases of drug development. The complexity and scale of data being generated has grown significantly and requires strong scientific contributions to… more
- Merck & Co. (North Wales, PA)
- …plans which describe the methodology to be programmed; applying statistical terminology and clinical data management concepts; CDISC and ADaM standards; ... clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.Support statistical… more
- Merck & Co. (South San Francisco, CA)
- …Biosciences (Pharmacology) department. The successful candidate will have direct line management of a research team responsible for the design, execution, and ... pharmacology strategy and provide scientific and technical leadershipEnsure high-quality data generation, analysis, and reporting to project teams, governance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Managed Markets, Legal, Compliance, and Finance. The position has high exposure to senior management and requires a highly motivated individual who is able ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, ... External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global Safety Lead(s) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …goals. Collaborate with clinical and regulatory teams to understand clinical data / patient outcomes, identify market opportunities, address regulatory ... maximize product potential Project Management and Coordination: Lead project management efforts to coordinate transition between clinical development and… more
- Aequor (Thousand Oaks, CA)
- …variances, and opportunities for improvement. Prepare and present reports to senior management . Supplier Relationships: Build and maintain strong relationships ... and supply of Pre- Clinical and Phase I Clinical Programs. The position requires project management ...and opportunities for improvement. Prepare and present reports to senior management . Supplier Relationships: Build and maintain… more
- Novo Nordisk Inc. (Atlanta, GA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...a difference? The Position Builds relationships and demonstrates the clinical outcome and benefits of Novo Nordisk Inc., (NNI)… more
