- 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)
- …other research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... 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)
- …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 Clinical Scientist Hematology 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Clinical Trial Information Disclosure Manager leads company operational ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large ... and/or complex clinical trials from study design, through execution,...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… 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
- J&J Family of Companies (Raritan, NJ)
- …in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials , assessment of ... Sr. Director, Senior Safety Officer- Johnson & Johnson Enterprise Innovation... Practices and PV regulatory requirements, the conduct of clinical trials and for the appropriate contributions… 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 guidance and ... GDQ functions to lead risk-based quality management 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
- J&J Family of Companies (Skillman, NJ)
- …+ Utilize scientific analysis principles to facilitate an understanding of product testing and clinical trial data for Skin Health and Hair Care products. + ... - 2407021764W **Description** Kenvue is currently recruiting for: ** Senior Scientist, Skin Health Clinical Research &... Research & Claims** This position reports into the Manager , Skin Health Clinical Research & Claims… more
- Actalent (Basking Ridge, NJ)
- …Associate ManagerJob Description + The Associate Manager , Site Start Up - Clinical Trial Insurance Leader is responsible for acquiring insurance documents on ... SOPs and guidelines. + Key responsibilities include maintaining and requesting clinical trial insurance, discontinuing insurance at study completion, maintaining… more
- J&J Family of Companies (Skillman, NJ)
- …acceptance. + Plan and support documentation and execution of GMP pilots and trials , safety, claim-support consumer testing, and other clinical and non- ... Senior Scientist, Baby Care R&D - 2407021457W **Description**... Scientist, Baby Care R&D** This position reports into Manager , Baby Care R&D and is based at Skillman,… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy… more
