- Merck & Co. (Rahway, NJ)
- …ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the ... person is responsible to manage a team of 6-14 Clinical Research Associates (CRAs) and to ensure...Operating Procedure (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP.)As line manager , the… more
- Merck & Co. (Rahway, NJ)
- …DescriptionPosition Description: Manager , Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global Clinical ... Management within the Global Data Management & Standards (GDMS) organization, the Manager Global Data Standards - Ops and Reference Data Management is responsible… more
- Merck & Co. (Rahway, NJ)
- …level value and implementation (V&I) goals, V&I plan, and outcomes research strategies, while considering customer input.- Designs, implements, and disseminates a ... portfolio of prioritized real-world evidence/outcomes research studies and outcomes research activities linked to value and implementation goals.- Manages study… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position manages ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... procedures, standardization of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Drafts development ... plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL...documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... difference. If this is your profile, we want to hear from you.Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Provide support ... for all aspects of Global Clinical Operations with a high degree of quality in...and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: We are looking for a manager to lead and manage the validation and testing activities for our platform products. This role will need ... provide documentation and evidence of validation activities to regulatory authorities. Clinical systems knowledge highly preferred.#EligibleforERP MRLGCTO#ONEGDMSNOTICE FOR INTERNAL APPLICANTSIn… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trial processes including experience in one or more key functions (eg, clinical research , clinical operations, data management, biostatistics, project ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... Experience Qualifications1 or More Years with BS. preferredExperience considered relevant includes clinical or basic research in a Pharmaceutical company, a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis Data Governance ... Communications Manager will be a critical part of the Center...in life sciences, pharma or informatics industry working with clinical trials, genomics / biomarkers, discovery, commercial, real world… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The purpose of ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryAs a ... Manager , Generative AI, you will be responsible for conceptualizing,...AI solutions that align with their needs. Drive the research , development, and implementation of generative AI models and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The ... Manager , Data Programming is a member of the Biostatistics...drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory ... Data Manager will be a key member of the Global...well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position will ... organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT,… more
