- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations ... other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… 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
- Aequor (Piscataway, NJ)
- …The S/MMC is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions Coordinates ... Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule:...Ability to establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress… 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
- Intra-Cellular Therapies, Inc (New York, NY)
- … Clinical Operations Department as a ** Clinical Trial Manager /** ** Senior Clinical Trial Manager ** who plays an important role in the ... or any other legally protected status. Clinical Trial Manager / Senior Clinical Trial Manager : Base Salary range $110K - $140K \#ITCI more
- Bristol Myers Squibb (Princeton, 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 (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
- Bausch Health (Bridgewater, NJ)
- …data, draw valid conclusions, and report on findings. Ability to assist in analysis of senior clinical trial data. Ability to interpret articles published in ... or collaborates on required tasks prior to commencement of senior clinical trials that include, but are... trial data to facilitate completion of seniorclinical trial reporting requirements, including report writing, clinical … 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
- Bristol Myers Squibb (Princeton, NJ)
- …to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key Responsibilities** + ... within the asset and/or indication + Responsible for managing clinical trial physician(s); attracting, developing and retaining... clinical trials (eg significant experience as a senior clinical leader), and exhibits all of… more
- J&J Family of Companies (Trenton, NJ)
- …of grants and contracts. **Key Responsibilities:** + Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored ... Senior Site Contract Manager - 2406185356W...and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of… 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 (Cranbury, 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
- Bristol Myers Squibb (Trenton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Manager of Biostatistics is a member of cross-functional ... organizational skills + Ability to: - learn regulatory requirements & clinical trial design, data analysis and interpretation, - work successfully within… more
