- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years relevant experience is required with a BSc required.Experience in clinical operations methods and processes in industry setting required.Experience ... regulations/EU 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)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), ... including experience in one or more key functions (eg, clinical research, clinical operations , data management, biostatistics, project management) required-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of External Vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the ... 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... strategies for cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify data anomalies, inconsistencies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, ... project or be partnered with a more senior project manager in support of a larger, more complex drug...Establishes and maintains a high performing team.Partners with the Clinical Team Leader to ensure a high performing … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...vendor selections and work alongside DS Procurement and DM operations to qualify preferred data vendors to ensure DSI… more
- IQVIA (Parsippany, NJ)
- …and quality metrics through regular review and reporting of findings as outlined by clinical operations management. * May collaborate with other clinical ... Job Overview Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking...with the reconciliation to the attention of the Study Manager and propose remediation plan. + Distribute key study… more
- Bausch Health (Bridgewater, NJ)
- …for Clinical Operations . May supervise direct/indirect reports including Clinical Trial Manager (CTM), Senior Clinical Research Associates and ... and issues (DMP, SAP, drug supplies, etc.). + Provides clinical operations input in the identification, evaluation,...one. Please ensure you have discussed with your current manager the intent of applying to a new role.… more
- Fresenius Medical Center (Somerville, NJ)
- **About this role:** As a Clinical Manager with Fresenius Medical Care, you will ensure that quality patient care is delivered while maintaining clinical ... functions, leading your business, and advanced leadership. As a Clinical Manager , you may advance your career...career into an Area Team Lead or Director of Operations role. **Our culture:** We believe our employees are… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... set-up, and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to ... be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC + Experience in global clinical trial operations including experience developing protocols and key study ... be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols… more
