- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilitiesSummary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with ... more focus areas (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness… 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)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... skills in continuous improvement, project management, change management, and risk management. ResponsibilitiesLeadership, Direction, and Strategy:Establishes Data Management strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current clinical practice ... to aid the SMT's signal identification efforts.Safety Expert - Signal Evaluation: Assists manager in assessing new signals.Safety Expert - Risk Mitigation &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …line with established targets and including communication of updates Ensures proactive risk identification and mitigation planning for assigned clinical trial ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools, and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project. As a project ... manager this position is accountable for partnering with the...accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …helping to ensure that the E&CDepartment takes a holistic view of risk management, considering broad organizational priorities as well as external insights. ... interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior… more
- Merck & Co. (North Wales, PA)
- …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- The Mount Sinai Health System (New York, NY)
- Senior Clinical Risk Manager The Senior Clinical Risk Manager serves as a resource to staff to enhance patient safety, promote patient safety, ... to protect the assets of the facility. The Senior Risk Manager supports the Risk ...of the Associate Director/Senior Director. 13. Serves as a risk management resource to all clinical and… more
- The Mount Sinai Health System (New York, NY)
- THIS IS FOR FUTURE OPPURTUNITIES The Clinical Risk Manager in the Department of Risk Management and Patient Safety is responsible for the day to day ... of Health and conducting risk management educational programs. The Clinical Risk Manager is responsible for the coordination and investigation of… more
- The Mount Sinai Health System (New York, NY)
- The Clinical Risk Manager reports to the Director of Risk Management and Patient Safety and is responsible for reviewing, summarizing, analyzing, ... risk management activities the Mount Sinai Health System (MSHS)., The Clinical Risk Manager conducts investigations and prepares reports as required by… more
- Merck (Trenton, NJ)
- … Clinical Research, the individual is responsible to manage/oversee a team of CTCs( Clinical Trial Coordinator). As line manager the role is critical to ... will work across the different country operations roles (eg CRM( Clinical Research Manager ), CRA( Clinical Research...within specified timelines with minimal oversight from the line manager . + Ability to proactively develop risk … more
- Northwell Health (New York, NY)
- …Job Description + Under the leadership of the Patient Care Director, the Manager Patient Care (PC) has 24/7 fiscal, clinical and operational accountability. ... unit or units within Northwell Health. + Utilizing the nursing process, the manager is responsible for creating a safe, healthy work environment that supports… more
- IQVIA (New York, NY)
- **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor management becomes ... the catalyst for advancing medical breakthroughs. As a ** Clinical Trial Vendor Manager ** , you'll play...meet our high standards of quality and service. + ** Risk Management Guru:** Proactively develop and maintain vendor-related … more
- Merck (Trenton, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). + Responsible for project management of the assigned ... and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed....COM). + Responsible for creating and executing a local risk management plan for assigned studies. + Ensures compliance… 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, to study...input into baseline timeline development and management + Leads risk assessment and identifies risk mitigation strategies… more
