- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Position manages the end-to-end delivery of data management services for assigned projects/ studies , collaborating with CROs and other vendors to ensure high quality ... Management and collaborates cross-functionally to ensure successful outcomes for projects/ studies .This position has strong knowledge of Electronic Data Capture/related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and ... PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies , literature, regulatory guidelines, and physiological/pharmacological aspects of the drug. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Position manages the end-to-end delivery of medical coding data for assigned projects/ studies collaborating with clinical and medical teams, CROs and other vendors ... strategy at the project and/or study level for a larger number of projects/ studies with greater complexity.Ensures medical coding deliverables for all studies … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Position manages end-to-end delivery of data management services for assigned projects/ studies , collaborating with CROs and other vendors to ensure high quality ... relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …purpose of this position is to analyze single Population PK/PD Phase 1 to 3 studies , simulate multiple dose scenarios, and write M&S study report for Phase 1 to 3 ... studies . This position demonstrates general knowledge of Phase 1 studies and multiple dose scenarios, PK/PD M&S analysis data structures and analysis tools… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good ... activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support the preparation, set-up, and execution and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data collection, data standards and data cleaning needs for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during the ... of all external data management deliverables for assigned DS Program / Studies by ensuring consistency of external data standards.Is accountable for quality delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Interventional, Non-interventional, Managed Access Programs, Investigator initiated studies and Collaborative Research.Support adherence to regulatory safety ... and safety reporting requirements across Medical Affairs activities: Interventional studies , Non-interventional studies , Compassionate Use or Managed Access… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation ... and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire project. Act as statistical expert in the assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for developing the Global Clinical Science Strategy and delivery of clinical studies in late stage developmentLead and manage the multiple late development and/or ... that adequate (Oncology) Clinical Science resources are deployed to clinical studies from end to end in collaboration with GCLs, Physician Scientists… more
