- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assigned clinical trials , document management and management of clinical trial management systems and archiving systems. Relationships Reports to a ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR... trials , including distribution of SUSARs to clinical trial sites Maintenance of systems, eg,… 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
- 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 ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership… 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)
- …ICH-GCP guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance ... The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data...principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills… 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)
- …oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications ... party data from diverse external providers for clinical trials , companion diagnostics trials ,...optimal approaches to support the collection of diverse external data types.Advises Study Data Manager … 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 ... and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Guidance Train Field Medical Affairs team on relevant disease state topics and clinical trial data . Review and approve resources for FMA Train ... comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies...Sales Teams on clinical trial data and Prescribing… 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 ... analysis dataset and TLFs transfers for ongoing and complete trials , confirm data use and output quality,...within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg, CRO); oncology, immunology, or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is ... party data from diverse external providers for clinical trials , companion diagnostics trials ,...meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when… 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)
- …years of experience in life sciences, pharma or informatics industry working with clinical trials , genomics / biomarkers, discovery, commercial, real world ... well as other research areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the… 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... clinical trials . This position will work closely... clinical trials . This position will work closely with other members… 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
- Merck & Co. (Ames, IA)
- …The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific to Ruminant animal health.- ... team takes a customer centric perspective using customer feedback and market intelligence data . Using this data , we design, develop and deploy products,… 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 ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… 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...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Aequor (Piscataway, NJ)
- …stakeholders. The S/MMC is expected to: Possess ability to understand and interpret clinical trial data , the literature and associated therapeutic conditions ... Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule:...Ability to establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress… more
