- Novo Nordisk Inc. (Plainsboro, NJ)
- …assigned clinical trials , document management and management of clinical trial management systems and archiving systems. Relationships Reports to a ... Manager (or above) within NACD. Manages mutually beneficial relationships... trials , including distribution of SUSARs to clinical trial sites Maintenance of systems, eg,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Aequor (NJ)
- …local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial experience Managing end to end supply chain Job Description: 100% ... This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical site performance through coordination and communication with CSSAs, CRAs and the Trial Manager (TM) for assigned trials , within the Therapy Area ... and reporting of key metrics In collaboration with the Trial Manager , support, prepare for and follow-up...to trial design, planning & conduct of clinical trials required In-depth knowledge & direct… more
- Novo Nordisk Inc. (San Antonio, TX)
- …the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project, MS ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and the application of those principles to trial planning and conduct of clinical trials Demonstrated computer skills (MS Office, clinical trial ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... and support of National Leaders/National Expert Panels for select clinical trials , in collaboration with Clinical...Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and trending to shape the future of Daiichi Sankyo clinical trials .Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project ... the build of industry expertise in innovation and optimization for clinical trials .-Utilize strategic conferences for information mining and networking,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required- 3+ Years… more
- Merck & Co. (North Wales, PA)
- …SummaryThis position contributes to the operational planning and execution of one or more clinical trials in the lung program. In this position, you will have ... management, communication, and collaboration skills in support of our clinical trials .Job ResponsibilitiesMay have specific operational responsibilities for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial outsourcing, health sciences or related field ( clinical trials ) required.Advanced WORD and Excel skills preferred.Excellent time management ... the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional...skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as...expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to… more
- Merck & Co. (Ames, IA)
- …The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific to Ruminant animal health.- ... the dairy industry.Assist research and development team with product evaluation, licensing trials and product development for all of our Company's Animal Health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is preferred A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...the knowledge gaps (for example: New TA knowledge, New Trial /Protocol etc.) Collaborate with Subject Matter Experts to ensure… more
- Catalent (St. Petersburg, FL)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... Manager , QA (Product Development)Position SummaryThe Quality Assurance Department...Master Shipper Labels, Process recipes, various technical protocols (Pre-Commercial Clinical Packaging Protocols, Process assessment, Method Validation, Bulk Mfg… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support drug development processes and global submissions as required for clinical trials . These include developing and validating SAS programs for ... centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of the Biostatistics... clinical trials . This position will work closely… more
