- 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)
- …(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 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)
- …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
- Ascendis Pharma (Princeton, NJ)
- …mark. We are a dynamic workplace for employees to grow and develop their skills. The Senior Manager , Clinical Trial Supplies (CTS), Oncology will work as ... CTS Oncology team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis… 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …to support regulatory filings (as relevant); and developing/maintaining relationships with key clinical trial sites and investigators in the therapeutic area. + ... successful implementation of CAPAs. Leading a multi-national team of clinical trial professionals, who are experts in...of relevant industry experience + Substantial experience of managing senior clinical operations staff in a global… more
- Bristol Myers Squibb (Princeton, NJ)
- … trials from study start to database Lock . **Position Summary / Objective** The Senior Manager , Clinical Data Management is a leadership role considered ... plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner...and written communication skill s + Communicate effectively with senior management and cross-functional teams + K nowledge of… 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
- Vitalief (New Brunswick, NJ)
- …is carried out as outlined. + Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active ... is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities. + Performs prospective reimbursement analysis according… more
- Taiho Oncology (Princeton, NJ)
- …and manages complex global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical ... Sr. Study Manager , Clinical Operations Princeton, NJ, USA...budget, recruitment and country/site selection strategies, and provision of clinical trial materials. + Serve as main… 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 ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… more
- Vitalief (New Brunswick, NJ)
- …Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions. Reasons to Work for Vitalief: + ... patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management. and other clinical trial activities for solid tumor, high… more
- WuXi AppTec (Plainsboro, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and WuXi Clinical Standard Operating… 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
- Bristol Myers Squibb (Trenton, NJ)
- …towards industry experience + Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical ... and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Managers develop collaborative relationships and work… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Senior Manager , Commercialization Competitive Intelligence (CI) plans and ... competitive intelligence and/or relevant pharmaceutical industry experience is preferred at Senior Manager level + Experience in hematology/oncology/cell therapy… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary Senior Manager , Commercialization Competitive Intelligence (CI) plans and ... portfolio, in alignment with stakeholder priorities and strategic imperatives. The Senior Manager in Commercialization CI Neuroscience will provide support… more
