- Tris Pharma (Monmouth Junction, NJ)
- …teams to mitigate issues in initiation and management of one or more clinical trials and monitor guidelines, IDMS charter, statistical analysis plans, data ... Data Safety Monitoring Board (DSMB) meetingsWorks with the Medical Directors to monitor and evaluate emerging clinical data; Reviews/interprets data to produce… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical sections of submission documents under guidance of CSL and/or Medical Monitor . Represents Clinical Development on Study Team and collaborates as team ... This position provides critical support to the CSL and Medical Monitor in the execution of Clinical Development functions.ResponsibilitiesStudy Strategy:… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of ... FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible...overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of… more
- Alternate Solutions Health Network LLC (Columbus, OH)
- …Provide skilled nursing care as ordered by the attending physician and observe and monitor patient conditions and notify case manager of any changes in the patient's ... methods to ensure patient and family understanding.Policies: Completes all clinical documentation following agency protocol and Medicare/Federal guidelines.Rules and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... of biological samples. The successful candidate is expected to establish, monitor validated bioanalytical methods and sample analyses of regulated bioanalytical… 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 ... across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will translate into… 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 ... proactive consideration, ensuring compliance with relevant Good x (eg clinical , distribution, manufacturing) Practice (GxP), external guidelines (eg International… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …controls in relevant process steps to ensure adherence to regulatory compliance. Monitor effectiveness of implementation of applicable clinical development ... strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of...strategy in close alignment with the GPT business strategy. Monitor and track implementation and break-down of the Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan ... and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager...the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... include reading of written documents and use of computer monitor screen frequently. Why you should join Catalent: Defined...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Lundbeck (MA)
- …Director, set individual and team performance goals for MSLs, and continuously monitor and report metrics to ensure progress toward strategic objectives RESOURCING ... Collaborate with Medical Affairs colleagues (Medical Directors, Medical Excellence, Clinical Development, Global Medical, etc.) to execute therapeutic area strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan ... immune disorders. Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager...the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Merck & Co. (South San Francisco, CA)
- …and licensing opportunities to capitalize on novel insights and complement internal pipeline. Monitor emerging biology and basic & clinical research within ... to direct reports and peers.Solid understanding of drug discovery and clinical development.Working knowledge of biomarker discovery, translational research, and data… more
- Catalent (Philadelphia, PA)
- …QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor , and sustain a robust and effective quality system that delivers ... for providing leadership and Quality Management support within each of the Clinical development supply division. This individual will have responsibility for Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and fully owns the forecasting assumptions that will feed the forecasting exercise- Monitor and communicate the performance of the indications in major markets (G8 , ... and proposed plans to address either/both in a timely manner- Clinical Development and Regulatory Support and Leadership for given indication(s)/tumor(s):- Represent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Dashboards. And in the R&D space including but not limited to clinical trial management system, drug labeling, and learning management system.Administration of ... identify availability issues with outsourced and internal solutions, performance issues. Monitor production and non-production environments. Monitor help desk… more
