- 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
- Merck & Co. (Rahway, NJ)
- …company's Research Labs, Global Clinical Development (GCD) and GCTO Global Clinical Trial Operations.Ability to identify problems, conflicts and ... (including the CTC Clinical Trial Coordinator, CRAs and-COM Clinical Operations Manager ).-Responsible for creating and executing a local risk management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates ... areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager ...strategic planning for future change. Subject matter expert on global clinical trial registration, result… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall ... and ensures continuity of site relationships through all-phases of the trial .Performs clinical study site management/monitoring activities in compliance with… 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, ... 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
- 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
- Novo Nordisk Inc. (Stamford, CT)
- … 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,...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical … 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 ... people. 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)
- …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)
- …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)
- …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
- 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)
- …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 suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... Company DescriptionAbout Insmed Insmed is a global biopharmaceutical company on a mission to transform...and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve… more
- 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… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates ... centered around rare diseases and immune disorders. **Summary** The Clinical Trial Information Disclosure Manager ...strategic planning for future change. Subject matter expert on global clinical trial registration, result… more
