- Vitalief (Newark, NJ)
- …transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Clinical Research Study Manager to join our exceptional team ... Work Location: Newark, NJ Responsibilities: + Reporting to the Director of Clinical Research Operations, provide support, establish workflows and processes to… more
- IQVIA (Parsippany, NJ)
- **Job Overview** Join our team as a Clinical Research Site Manager , where you'll play a crucial role in ensuring our study sites operate seamlessly and ... with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the… more
- J&J Family of Companies (Raritan, NJ)
- …as described in GCO procedural documents. Primary responsibilities: + Collaborate with Functional Manager (FM)/ Clinical Research Manager (CRM) for ... and Johnson is currently seeking an Senior Local Trial Manager . This position can be located remotely within the...including GCP and local regulatory requirements + Experience with clinical research applications (CTMS, TMF, EDC, etc.)… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Manager Clinical Study Lead**...role applies to internally sourced studies and studies out-sourced to Clinical Research ... in this role looks like:** + Leads the cross-functional study team responsible for clinical study...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research … more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Manager Clinical Statistician Date: Jan 16, 2025...of study designs and data analyses for clinical studies . + Provides study design ... to make a difference with. **The opportunity** The Senior Manager Clinical Statistician is a skilled statistician...statistician with training and experience in drug development and clinical research . You'll be expected to provide… more
- IQVIA (Boonton, NJ)
- …essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies ... core project team. * Accountable for the execution of clinical studies , or assigned portion of ...clinical trial conduct, and skill in applying applicable clinical research regulatory requirements ie ICH GCP… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …trials, across all therapeutic areas, around the world. In partnership with Clinical Research , Medical Affairs and Development Operations functions, ensures that ... Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report...4+ years of trial management experience **PREFERRED:** + Extensive clinical research knowledge and cross-functional understanding of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … trials, across all therapeutic areas, around the world. In partnership with Clinical Research , Medical Affairs and Development functions, ensures that all ... consents, case report forms, monitoring plans, investigator brochures and clinical study reports + Must be able...regulations), ICH Guidelines, and GCP governing the conduct of clinical studies + Working knowledge and experience… more
- Daiichi Sankyo Inc. (Basking Ridge, 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 ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....the CSL and Medical Monitor in the execution of Clinical Development functions. **Responsibilities** + Study Strategy:… more
- System One (Florham Park, NJ)
- …Change Orders, Lab Agreements, and any other type of agreements needed for clinical studies ). + Actively managing other clinical financial obligations. ... Manager , Clinical Business Operations Job Category:... Clinical Development on planning and management of clinical study -related outsourcing activities with enough communication.… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson is currently seeking an Analyst II, Clinical Data Manager . This position can be located in Raritan, NJ; Titusville, NJ; or Spring House, PA. At ... Johnson & Johnson, we all belong. The Analyst II, Clinical Data Manager is a professional individual...deliverables are achieved. + Create key functional plans (eg study Integrated Review Plan) ensuring appropriate quality, scientific content,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam + Line Manager for CS team and serves as key functional advisor or ... studies and ensures scientific integrity and interpretation of study data of a clinical development program....Applies advanced scientific expertise to propose, design, and execute clinical research and development studies … more
- Bristol Myers Squibb (Summit, NJ)
- … Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Responsible ... team members. + Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable. +.... **Experience Requirements** + 5+ years of experience in clinical science, clinical research , or… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …data quality and adherence to established coding conventions. In collaboration with the Study Data Manager , monitors coding metrics and trends on a scheduled ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. **Job Summary:** The … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample ... development. **EXAMPLE RESPONSIBILITIES:** + Acts as biostatistics lead on clinical studies or other non-molecule projects. +...projects and / or the statistical analysis plan and clinical study endpoints for assigned products. +… 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… 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 medium ... and immune disorders. **Summary** Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- AbbVie (Florham Park, NJ)
- …design, analysis and reporting of clinical trials or other scientific research studies . Independently develop protocols and/or statistical analysis plans (or ... Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to… more
- Grifols Shared Services North America, Inc (Newark, NJ)
- …subsequent drafts of clinical study reports from data generated from clinical studies , using ability to understand and interpret the data from tables and ... produces Clinical Development Documents, such as final Clinical Study Reports, abstracts, white paper reviews...subsequent) drafts of documents or abstracts/posters from data from clinical studies or other sources such as… more