- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical ... a project manager for other activities involving assigned product(s) or clinical studies , as needed.QualificationsSuccessful candidates will be able to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical ... a project manager for other activities involving assigned product(s) or clinical studies , as needed.QualificationsSuccessful candidates will be able to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical ... a project manager for other activities involving assigned product(s) or clinical studies , as neededQualificationsSuccessful candidates will be able to meet… more
- Merck & Co. (Rahway, NJ)
- …'end-to-end' integrated clinical supply chain across the full of our company's Research Laboratories portfolio of clinical trial s .- GCS is accountable for ... within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM)...- Responsible and accountable for establishing the timelines for clinical supply needs per study and providing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities: Study Strategy: Drafts development plan under… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our Research & Development ... teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of standard hierarchy structures and user access controls for all clinical studies . This position may have direct reports and/or dedicated ... around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a...work with members of Data Operations, DM, and Biostatistics, Clinical Study teams, IT/Information Services and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including but not limited to Translational Science, Companion Diagnostics, Biosample Management, Clinical Study Teams, Central & Analytical Laboratories and ... Daiichi Sankyo clinical development.Contributes on biomarker related sections of clinical study protocols and ensure instructions on sample collection,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This position ... is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is...supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various work streams with key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose ... financial reconciliation and negotiation of Vendor contracts prior to study termination and contract closure. Manages all aspects of...to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services… more
- Mount Sinai Health System (New York, NY)
- …Activities of Ongoing Clinical Trials** + Assist in the activities related to clinical research studies including but not limited to answering phone ... safeguarding of patients' rights in research **Manage Study Data of Ongoing Clinical Trials Under...and specimen handling + Under the supervision of the clinical research manager , the coordinator… more
- Mount Sinai Health System (New York, NY)
- …the Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for ... clinical research data. 2. Coordinates the clinical assessments of the study subjects including...Independently obtains informed consent for other clinical studies . 8. Mentors Clinical Research … more
- Mount Sinai Health System (New York, NY)
- …The Center for Psychedelic Therapy Research is looking for a full-time clinical research project manager in a high-profile, cutting-edge clinical ... manager will create and execute plans for complex research projects that may include clinical trials and biological studies of PTSD. This position… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our ... pivotal role in the centralized development and negotiation of clinical research budgets. As a self-directed professional...you will be responsible for crafting budgets for various clinical studies , ensuring compliance with all relevant… more
- Hackensack Meridian Health (Hackensack, NJ)
- …our mission to transform healthcare and serve as a leader of positive change. The Manager of Regulatory Clinical Research for Oncology manages the Regulatory ... agencies. **Responsibilities** A day in the life of a Manager , Oncology Regulatory, Clinical Research ... trials. + Ensures that all clinical research staff and all research studies… more
- Mount Sinai Health System (New York, NY)
- …CRSU office (including pre-award, post award and QAP). ** Clinical Research Responsibilities:** + Responsible for coordinating study enrollment, establishing ... and assist in the administration and plan of the research program. The Clinical Program Manager...the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart… more
- Meta (New York, NY)
- …Health and Wellbeing team is seeking a highly experienced clinical study manager to support clinical research operations. The Clinical Study ... device research . 8. Demonstrated track record of clinical study operational execution, participation in ... research organizations, and with virtual or remote clinical studies . 13. Experience with multi-center … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is… more
