- 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)
- …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)
- …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)
- …with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure in collaboration with Global Development Operations ... and proactively represented at program level and along the clinical trial process in support of a...(GDO) ( Global Clinical Operations / Clinical Quality Management or other RD business process owners… 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 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)
- …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
- 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 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …+ Collaborates with the TA Medical Lead, CTL, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the study protocol ... in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Trial Physician (CTP) in the Worldwide...to medical monitoring-related activities. + Partners with CTL and global Trial Manager (GTM) to… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Global Trial Optimization** **Department** **: 1467- Global Clinical Trial Services** **SUMMARY:** The Senior Manager , Global Trial ... & enrolment support in clinical trials working closely with clinical trial management, CROs and global monitoring. + _Supports the development… more
- Bristol Myers Squibb (Madison, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager , Global Feasibility is an experienced clinical research professional who has ... a strong proficiency in the curation and analysis of clinical trial intelligence data and its application...development program. **Key demonstrated skill level for a Senior Manager , Global Feasibility are as follows:** +… 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
- Bausch Health (Bridgewater, NJ)
- …valid conclusions, and report on findings. Ability to assist in analysis of senior clinical trial data. Ability to interpret articles published in medical and ... Bausch Health is a global company that develops, manufactures, and markets a... trial data to facilitate completion of seniorclinical trial reporting requirements, including report writing, clinical … 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
- Bausch Health (Bridgewater, NJ)
- …or all of the following functions or processes are highly preferred: clinical supply pack/label/distribution, clinical trial operations, project management, ... strategy and execution + Assist in the management of the governance committee for global clinical operations and global clinical supply chain + Work… more
