- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...management systems and archiving systems. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools, and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... planning and execution of clinical studies ,...issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key… 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 ... and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is... Manager role is primarily a tactical study delivery role, reporting into an Associate … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …capacity management in accordance with budgetary requirements and emerging priorities to ensure studies are delivered as planned and critical study timelines are ... centered around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic development, oversight, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as ... and represents function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... planning and execution of clinical studies ,...issues with the reconciliation to the attention of the Study Manager and propose remediation plan. +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for this role. The position can be based in Armonk, NY or Basking Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports the Clinical ... sites may be required to assist with monitoring clinical studies . **A typical day as CSAM...like:** + Lead/oversee the planning and management of a clinical study in an assigned region(s) in… more
- Actalent (Basking Ridge, NJ)
- …Clinical Study Leader or Clinical Study Associate Manager . This person will support internally sourced studies and studies out-sourced to ... Specialist/In-house CRA provides technical and administrative support to the clinical study team(s) responsible for clinical... Clinical Research supporting Clinical Trial Managers/ Clinical Research Manager on studies … more
- WuXi AppTec (Plainsboro, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... **Essential Job Functions:** + Responsible for all aspects of clinical monitoring and required reporting, including pre- study ...or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II… more
- Merck (Trenton, NJ)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential ... Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible...Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions… more
- Sanofi Group (Bridgewater, NJ)
- …project leader and/or team leader. + Provide high quality input into the design of the clinical study , the setup and conduct of the study + Accountable for ... statistical insight into interpretation and discussion of results sections for the clinical study report and/or publications to ensure the statistical integrity… more
- Terumo Medical Corporation (Somerset, NJ)
- Professional and Clinical Training Manager Date: May 8, 2024 Req ID: 3138 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: TIS ... Products. **Job Summary** In this fast paced and critical role, Professional and Clinical Training Manager will evaluate and develop training for all associates,… more
- System One (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... Job Title: Associate Director, Biostatistics Client - Global Pharmaceutical Company...rare diseases and immune disorders. This position leads complex studies in study design, statistical analysis and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... Summary This position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Bristol Myers Squibb (Trenton, NJ)
- …protocols. + Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study ... . **Key Responsibilities** + Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address… more
- Bristol Myers Squibb (Princeton, NJ)
- …protocols. + Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study ... difference. + Collaborates in design of innovative and efficient clinical trials, including the selection of study ...and other public release of information + Manages multiple studies to ensure consistency and adherence to standards within… more
