- 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)
- …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
- 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
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part...project finances. Req * Knowledge of clinical trials - Knowledge of clinical trial ... of clinical trial delivery, leading and working alongside clinical ...by bringing new drugs to the market faster. The Senior Clinical Lead is a member of… 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 ... global execution of large, complex clinical trials from study design through study...and studies outsourced to CROs, so we need a Senior Clinical Trial Manager… more
- Bausch Health (Bridgewater, NJ)
- …for Clinical Operations. May supervise direct/indirect reports including Clinical Trial Manager (CTM), Senior Clinical Research Associates and ... Clinical Research Associates (Sr. CRAs and CRAs) and Clinical Trial Assistants (CTA).. **Responsibilities** + Manage...the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and… 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 ... feasibility information to support early assessment of operational feasibility for conducting clinical trials . + Lead study level engagements to obtain, analyze… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … clinical programs, forecasting Investigational Product (IP) supply requirements for multiple clinical trials , and for managing the IP distribution process to ... one or more clinical trials . Activities are performed on time,...sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical… 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)
- The Senior Manager , Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... and other GDQ functions. Lead risk-based quality activities on all Regeneron-sponsored clinical trials , inclusive of issue management and providing continuous… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred + If you have a high attention to detail; ... The Sr. Manager , Regulatory Affairs will report to the Global...the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Development Operations & Portfolio Management (DO&PM) Vendor & Relationship Management (VRM) position is responsible to ensure that ... documentation maintenance, and SOP compliance checks. As a Sr Manager DO&PM Vendor and Relationship Management, a typical day...of 8 years of experience and success in a clinical trial /life sciences management role. Experience working… 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
