- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... 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
- Merck & Co. (North Wales, PA)
- …one or more clinical trials. Under the oversight of a clinical scientist, study manager , or program lead , the Clinical Specialist may be ... Job DescriptionJob Summary:The Clinical Specialist position is a combined position of clinical scientist and study management duties supporting… more
- Daiichi Sankyo, Inc. (Bernards, 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...and quality deliverables. Lead the development of the clinical study plan including critical path activities… 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
- Aequor (South San Francisco, CA)
- …delivery and analysis of biomarker and diagnostics biosamples within one or more clinical projects or clinical studies . He/she is also responsible ... across therapeutic areas Accountable for the development of a project's and/or clinical study 's biomarker and diagnostics biosample collection, processing and… more
- Merck & Co. (Rahway, NJ)
- …teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development...ensures proper allocation of drug product as needed across studies within assigned program(s) . - Responsible for identifying… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager , Team Manager (GCTM-TM) is responsible for line ... and strategic support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands throughout… 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 ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The **Senior Manager Clinical Study Lead ** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of ... studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug...awareness of relevant industry trends + Ability to build, lead and develop productive study teams and… more
