- Novo Nordisk Inc. (Plainsboro, NJ)
- …with the planning & successful delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North ... across NACD by assuring training plans (NACD level & project level) are developed & deployed within a staff...to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality ... 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. (Irvine, CA)
- …the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project ... 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)
- …expertise to project /study teams to optimize study-specific clinical trial processes.May participate in process improvement initiatives.Qualifications: ... 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)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… 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)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead. -Leads team...initiation, interim and close out visitsExperience as a CRA Manager , Lead CRA or Project ManagerRare disease… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trending to shape the future of Daiichi Sankyo clinical trials .Responsibilities- Process Improvement, Innovation and Optimization (IO):- Project manage GCO ... matrix environment including project management preferred- Experience in clinical trial design and improvement activities, harmonization/optimization, and… 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)
- …to support drug development processes and global submissions as required for clinical trials . These include developing and validating SAS programs for ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is... clinical trials . This position will work closely… more
- Axelon Services Corporation (Atlanta, GA)
- …This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development ... studies during phases 1-4. The individual must partner closely with clinical , regulatory, quality and production associates to ensure timely delivery of supplies to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to...sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... make a significant impact on the way that the Harman's site operates. The Manager , Supply Chain - Warehouse will lead a shift consisting of Warehouse Materials… more
- BioAgilytix (Durham, NC)
- …sound product submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory ... life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects… 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 ... QA Product Manager Position SummaryThe QA Product Manager ...analysis to eliminate future problems. Participates in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- Sunrise Systems inc (Atlanta, GA)
- Job Title: Trial Supplies Manager Job ID: 24-02153...Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial experience Managing end to end ... 07901 Duration: 06 Months of W2 Contract 100% Remote Manager prefers local candidates (will consider non local candidates...responsible for the supply planning and inventory management of clinical supplies required to support global clinical … more
