- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Safety Scientist Product Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical studies, ... in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation - Project Management:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study...with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... within the Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Efficiency / Continuous Improvement:Provides comprehensive data management expertise to project /study teams to optimize study-specific clinical trial ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordination. This position collaborates within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the ... for planning, managing, and coordinating projects within DSI CSPV and global clinical safety and epidemiology function. Deliver the project according to… 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 ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking...teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or related role in a biotech or pharmaceutical companyDemonstrated success as a project manager /leader in planning and executing strategies for global drug ... rare diseases and immune disorders.SummaryThis position is responsible for providing project management, drug development expertise to Global Project Teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business analyses or consulting experience. required and- Prior work experience as a project manager , project lead, or similar role within pharmaceutical ... and people with disabilities. SummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the development and creation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(ICH) guidelines.The Manager , Study Associates will ensure the SAs provide clinical administrative support to the study teams and support interactions with the ... and provide this feedback through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in departmental and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... expertise and trending to shape the future of Daiichi Sankyo clinical trials.Responsibilities- Process Improvement, Innovation and Optimization (IO):- Project … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. ... Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with...and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with strong preference for study feasibility, and/or study design optimization and/or clinical operations project management preferably with a sponsor company at ... (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... coaching for progressive skills development; Assessing and training product knowledge and clinical selling; Teaching and coaching managed care overview, as well as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Data & Analytics, Logistics & Distribution, Patient Support Solutions, Clinical Operations Pharmaceutical industry experience helpful, but not required Ability ... people skills Demonstrated leadership qualities with the ability to act as project lead in the development and implementation of projects, processes and programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or more key functional areas (eg clinical research & development, clinical science, clinical quality assurance, project management) preferredStrong ... around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, ... etc., under the direction of Director, Compliance Policy, Training and Communications. Project manage various teams to build creative training programs from… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of the established… more
