- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trial processes including experience in one or more key functions (eg, clinical research , clinical operations, data management, biostatistics, project ... research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting ... in accordance with DS standards. Act as the project manager of the clinical study team to...or More Years with PharmD/PhD preferredExperience considered relevant includes clinical or basic research in a pharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position manages ... 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)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to...More Years with BS required- Experience considered relevant includes clinical or basic research in a Pharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Responsible for ... (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Manager ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Manager , ... coaching for progressive skills development; Assessing and training product knowledge and clinical selling; Teaching and coaching managed care overview, as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummarySupport the PVQA ... interventional, non-interventional, investigator-initiated trials, Managed Access programs and Collaborative Research to the highest quality standards globally end-to-end end… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The purpose of ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position is ... the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis Data Governance ... Communications Manager will be a critical part of the Center...in life sciences, pharma or informatics industry working with clinical trials, genomics / biomarkers, discovery, commercial, real world… more
- Insmed Incorporated (Bridgewater, NJ)
- …cross-functional collaboration with teams such as Commercial, Market Access, Sales, Research , Clinical , Finance, and LegalEstablish external and internal ... our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryAs a ... Manager , Generative AI, you will be responsible for conceptualizing,...AI solutions that align with their needs. Drive the research , development, and implementation of generative AI models and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Manager ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting… more
