- 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
- 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)
- …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)
- …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)
- …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
- 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
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials....Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying… more
- Actalent (Morristown, NJ)
- Role: Sr. Clinical Trial Manager (Therapeutic Area:...Summary: The Senior Clinical Trial Manager will be responsible for the global execution ... studies outsourced to CROs, so we need a Senior Clinical Trial Manager who has...Experience Needed: + Bachelor's degree + 5+ years of global trial management experience (pharmaceutical/biotech/CRO) + Experience… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and skills ... may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC + Experience in global clinical trial operations including experience developing protocols ... may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing… more
- Actalent (Bernardsville, NJ)
- …of 5+ years of relevant industry experience. 4+ years of Direct experience managing global clinical trial operations is a must, including experience ... will lead the cross-functional study team responsible for the global execution of large, complex clinical trials...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam + ... The Senior Manager , Hematology, Clinical Scientist leads in...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
