- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and… 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 ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… 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 ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... efficiency and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve business… more
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... by bringing new drugs to the market faster. The Senior Clinical Lead is a member of...Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying… more
- Bristol Myers Squibb (Madison, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager , Global Feasibility is an experienced clinical research professional ... a strong proficiency in the curation and analysis of clinical trial intelligence data and its application...research development program. **Key demonstrated skill level for a Senior Manager , Global Feasibility are as follows:**… more
- Actalent (Morristown, NJ)
- …In addition, 100% of their drug candidates are invented and developed in house! Summary: The Senior Clinical Trial Manager will be responsible for the ... internally sourced studies and studies outsourced to CROs, so we need a Senior Clinical Trial Manager who has experience managing Third-Party Vendors.… more
- Actalent (Bridgewater, NJ)
- …in development phases I-III. **MUST BE LOCAL TO GO ONSITE 2-3X PER WEEK** Summary: Senior Manager , Global Trial Optimization (GTO) will lead program or study ... + Education: Minimum Bachelors (Masters Preferred) + Direct experience managing global clinical trial operations is a must, including experience developing… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity ... on clinical studies and programs. As a Senior Manager in Hematology Clinical ...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Clinical Data and Reporting Standards (CDARS) ... and reporting standards in support of AbbVie's portfolio of clinical trials and ensuring AbbVie's conformance to CDISC standards...to CDISC. + Review and provide feedback on SDTM Trial Design Domains + Oversee the creation of SDTM… more
- Bristol Myers Squibb (Madison, NJ)
- …of the markets related to specified asset(s) in WWMH. **Key Responsibilities** The Senior Manager of Medical Communications is accountable for the following: ... Professional (CMPP), and ISMPP active member highly desired + Understanding of clinical trial design and execution, statistical methods and clinical trial… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input ... + Proficient in the navigation of intelligence database(s) + Prior experience in Clinical Trial Operations + Basic knowledge in the monitoring and sourcing… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... The **Sr Manager , Clinical Drug Supply & Logistics**...orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely… more
- Sanofi Group (Bridgewater, NJ)
- …management with relevant experience in biotech/pharma with a strong emphasis on pathobiology and clinical trial development, MBA is a plus + Ability to build ... Pre/Post product launch aspects. Strong relationship/Cross Functional Interface. + Partner with Clinical Study Operations to ensure a robust clinical feasibility… 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 ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… 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 ... Management System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs. +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …across multiple therapeutic areas (ie, understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead ... related subject area + 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related… 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 ... diseases and immune disorders. **Summary** The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi… more
