- 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. (Los Angeles, 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)
- …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
- Merck & Co. (Rahway, NJ)
- …of Finance contact for a wide range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub ... Team, Clinical Trial Team, Outsourced Trial Team, and Partnerships, Alliances, and Collaborations Team for...Team, and Partnerships, Alliances, and Collaborations Team for all project issues related to study budget, site and vendor… 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)
- …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)
- …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
- 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)
- …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. Applies GCP principles to ensure all external data… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and company SOPs regarding adverse event reporting from post-marketing sources and clinical trials complaint handling Ensures local/affiliate SDEA templates meet ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...major programs or initiatives, and may function in a project leadership role Regulatory compliance: Ensures compliance with all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to… 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
- 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
- DivIHN Integration Inc (San Diego, CA)
- …please contact one of our Talent Specialists Sivanesan at 224 369 0756 Title: Clinical Trial Assistant (CTA) Location: San Diego, CA Duration: 12 Months ... have experience working with biological specimens and data sets, ideally with some clinical trial familiarity Will be providing general administrative support to… more
