- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... members for each study. Establish appropriate work procedures/guidance, logs, templates, quality procedures, risk impact assessment mitigation procedures, to… more
- Insmed Incorporated (San Diego, CA)
- …with GTx Technical Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. Identify ... for review and approval of master batch records for pre- clinical / clinical and / or pre-commercial product.Manage the quality aspects of clinical… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities ... to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …objectives. Implement and use efficient project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...experience At least 5 years of experience as a Clinical Trial Manager Experience with global … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for … more
- Merck & Co. (Rahway, NJ)
- …compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or ... Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure...safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and indirect compliance, handling state tax audits and notices, evaluating state tax risk , and ensuring realization of state credits and incentives for all Novo ... internal stakeholder relationships to gain business understanding and provide expert quality deliverables. This includes securing an understanding of acquired assets… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project plans across functional teamsDefines the interdependent deliverables and ensures that quality , risk , cost, time are managed within the overall approved ... discipline and its application to drug development required to deliver time, cost, quality , and risk management to teams.Demonstrated results in creating and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....based on current regulatory environment and competitive landscape Assess risk and advise on mitigation strategies to meet overall… 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 ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- McLaren Health Care (Davison, MI)
- …education programs and other educational materials addressing areas of concern on quality and patient safety.f. Provides risk and patient safety orientation ... state license as a registered nurse. 3. Certified Professional in Healthcare Risk Management (CPHRM), Certified Professional in Healthcare Quality (CPHQ) or… more
- Abbott (Plano, TX)
- …TX or Austin, TX sites currently has an opportunity for a ** Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager ** . The Clinical Risk ... and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as… more
- AdventHealth (Celebration, FL)
- ** Clinical Risk Manager ** **Location: AdventHealth Celebration-** **400 CELEBRATION PLACE, Celebration, 34747** **All the benefits and perks you need for you ... of illness and disease **The role you'll contribute:** The Clinical Risk Manager (CRM) is...or claims field AND + Experience in process improvement/patient safety/ clinical risk management/ quality activities +… more
- Cleveland Clinic (Vero Beach, FL)
- …one of the most respected healthcare organizations in the world. We are looking to add a Clinical Risk Manager to the team. The Manager directs the ... risk management program on a day-to-day basis and implements clinical risk management initiatives to ensure operational alignment with assigned… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Clinical Risk Manager reports to the Director of Risk Management and Patient Safety and is responsible for reviewing, ... management activities the Mount Sinai Health System (MSHS)., The Clinical Risk Manager conducts investigations...and Culture of Safety principles preferred. + Knowledge of clinical quality , patient safety, patient experience and/or… more
- Sunrise Senior Living (Mclean, VA)
- …For me, that's a big breath of fresh air."_** **_- Sunrise Leader_** The Clinical Risk Manager is responsible for identifying, evaluating and mitigating ... ever worked, simply because of the people. We provide quality care in an environment that feels like home....the overall operation and strategy of the Legal & Clinical Risk Management program. Operating as a… more
