- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned with the planning & successful delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) ... in the pharmaceutical industry (Pharma/Biotech/CRO) Previous experience leading cross-function clinical trial operations teams preferred Expert in ICH-GCP… more
- Merck & Co. (Rahway, NJ)
- …range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial Team, ... and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist… 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
- 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
- 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
- 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
- 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 ... internally sourced studies and studies outsourced to CROs, so we need a Senior Clinical Trial Manager who has experience managing Third-Party Vendors.… 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
- 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
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a ** Senior Manager , Clinical Sciences** to lead in the development, evaluation, planning and execution of clinical studies and ensures ... scientific integrity and interpretation of study data of a clinical development program. The Senior Manager...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assisting… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Clinical Data and Reporting Standards (CDARS) ... and reporting standards in support of AbbVie's portfolio of clinical trials and ensuring AbbVie's conformance to CDISC standards...to CDISC. + Review and provide feedback on SDTM Trial Design Domains + Oversee the creation of SDTM… more
- Merck (Rahway, NJ)
- …range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial Team, ... and improve lives. **Position Description:** Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist… 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
- Bristol Myers Squibb (Princeton, NJ)
- …treatment we pioneer. Join us and make a difference . **Position Summary** The Senior Manager of Biostatistics is a member of cross-functional development teams ... organizational skills + Ability to: - learn regulatory requirements & clinical trial design, data analysis and interpretation, - work successfully within… more
- Bristol Myers Squibb (Trenton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager of Biostatistics is a member of cross-functional development ... organizational skills + Ability to: + Learn regulatory requirements & clinical trial design, data analysis and interpretation, + Work successfully within… more
