- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has ... medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the ... of 7 years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry setting. required… more
- Merck & Co. (North Wales, PA)
- …clinical development teams, the Biomarker (BMx) leads will develop asset-specific clinical biomarker strategy by incorporating critical insight from discovery ... BMx strategy : collaborate across different LFs, to formulate testable clinical and translational hypotheses; and develop clinical biomarker and translational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies in one or several programs.Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and ... (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference ... (eg, Executive Committee). Provides input to Clinical Operations on monitoring plan (eg data fields...enrollment, retention and protocol compliance for consistency with study strategy ; reviews emerging clinical data … more
- Merck & Co. (North Wales, PA)
- …database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (North Wales, PA)
- …heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data ... trial participants, in the right way to enable the Clinical Research to analyze data for efficacy,...Trials domain to help us implement our vision and strategy to enable the software products within the Trial… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... from you.The Sr Medical Director provides medical leadership for medical affairs strategy , planning and supportive tactics mainly for GU therapeutic area. This role… more
- Merck & Co. (Rahway, NJ)
- …Manager will advance the purpose and aspiration of our Company 's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations , Data Management, Scientific Operations etc) ... Summary The purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in how we engage customers. Leverage analytics and market research to inform strategy and opportunities for growth Business Operations Management: Develop and ... About the Department Our Commercial Strategy and Marketing group creates and delivers human-centered...on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing data collection, data ... data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) for establishing data collection, ... SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company, or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the ... governance approach/framework with a continuous improvement mindset. Coordinate GRA's data strategy with broader corporate IT projects and objectivesCollaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. ... management, change management, and risk management. ResponsibilitiesLeadership, Direction, and Strategy :Provides data management (DM) expertise and guidance to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. ... myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based...surface sampling, related to Raritan manufacturing processes, either for clinical trials and commercial operations in a… more
- Merck & Co. (North Wales, PA)
- …consisting of functional teams across market research, data strategy , forecasting, resource effectiveness, measurement, marketing/sales operations , digital ... commercial analytics, data science, customer engagement, data strategy , population health, competitive insights, marketing operations , medical & … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...management, placement and delivery to US and CA warehouses operations for US and CA Clinical Trial… more
- Eisai, Inc (Nutley, NJ)
- …strengthen compliance with GDPR, HIPAA, CSL, and other relevant security and data privacy standards. Your responsibilities span security operations , risk ... effectiveness.Remediate control deficiencies and investigate potential unlawful actions.Oversee system data retention standards and verify system operations .Manage… more
