- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... around rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction...The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... department, (subset of) NACD and/or as part of a global team and as aligned to a business case,...trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, IRBs, clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), ... learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is preferred A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...above within CMR Training & Knowledge Management. Collaborates with global and CMR leaders and stakeholders to develop comprehensive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Degree preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical ... preferred.Excellent time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...clinical studies, under the supervision of the Study Manager role the Study Associate Manager within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data ... services they provide to support drug development processes and global submissions. This position provides expertise within Data Management...or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab… more
- Merck (Trenton, NJ)
- …a timely manner and in coordination with the study + CRM and CRA. + Interface with GCTO( Global Clinical Trial Operations) partners on clinical trial ... the individual is responsible to manage/oversee a team of CTCs( Clinical Trial Coordinator). As line manager...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Ascendis Pharma (Princeton, NJ)
- …are a dynamic workplace for employees to grow and develop their skills. The Senior Manager , Clinical Trial Supplies (CTS), Oncology will work as an integral ... CTS Oncology team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis… more
- Bristol Myers Squibb (Princeton, NJ)
- …of concept, full development and/or across marketed products. + Experience in conducting global clinical trial programs across major worldwide markets, ... personal lives. Read more: careers.bms.com/working-with-us . Position Title: Executive Director, Global Trial Management, TA Head Immunology/CV Functional Area… more
- Bristol Myers Squibb (Princeton, NJ)
- …portfolio. + Collaborate with the TA Medical Lead, CTL, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the Medical study ... Generation (MEG) Lead - Cell Therapy (CT) role in Global Medical Affairs manages the evidence generation for the...MD preferred, but not required, plus 2-3 years of clinical trial experience, either in industry or… more
- Merck (Trenton, NJ)
- …Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). + Responsible for project management of the ... research knowledge is required. + Strong understanding of clinical trial planning, management and metrics is...goals, purpose and mission of our Company Research Labs, Global Clinical Development (GCD) and GCTO. +… more
- Merck (Trenton, NJ)
- …Clinical Research Director) as needed. + Works in partnership with GCTO ( Global Clinical Trial Operations) country operations, finance, regulatory ... **Job Description** With support of Sr CRA ( Clinical Research Associate) and/or CRA Manager ,...Related CR ( Clinical Research) experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC… more
