- 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)
- …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)
- …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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …primary site contact and site manager throughout all phases of a clinical research study , taking overall responsibility of allocated sites. Actively develops ... continuity of site relationships through all phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,… 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
- Bristol Myers Squibb (Princeton, NJ)
- … Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Supports ... preferred) **Experience Requirements** + Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Basic knowledge of… more
- Lilly (New York, NY)
- …Summary** We are seeking an experienced and highly motivated Advisor (Senior Manager )/Senior Advisor ( Associate Director) Clinical Biostatistics to provide ... study protocols, statistical analysis plans, technical statistical programming specifications, clinical study reports, and regulatory submissions and queries.… more
- J&J Family of Companies (Trenton, NJ)
- …dull moment. Our team focuses on future development of the Impella platform, including clinical studies , data science and new clinical and physiological ... Senior Clinical Research Associate - 2406171534W **Description**...for consistency with case report form, and determine if clinical study subject documentation is within parameters… more
- Merck (Rahway, NJ)
- …primary site contact and site manager throughout all phases of a clinical research study , taking overall responsibility of allocated sites. Actively develops ... of site relationships through all phases of the trial. + Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor… 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 ... **Job title** : Associate Statistical Project Leader (Sr. Manager ),...into interpretation and discussion of results sections for the clinical study report and/or publications to ensure… 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
- AbbVie (Madison, NJ)
- …SDTM Trial Design Domains + Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer's Guides for both FDA and PMDA submissions. + ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Clinical Data and Reporting Standards (CDARS)...governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment… more
- Terumo Medical Corporation (Somerset, NJ)
- Professional and Clinical Training Manager Date: Apr 9, 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
- Merck (Rahway, NJ)
- **Job Description** **Overview** : The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is ... development and implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's… more
