- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with ... (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … safety surveillance and risk management , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, ... around rare diseases and immune disorders. Summary The Director, Clinical Safety , will be a product ...topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management … more
- Merck & Co. (North Wales, PA)
- …for the position:Serve as a statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support ... design and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive… more
- Novo Nordisk Inc. (San Antonio, TX)
- …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities ... a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific… more
- Merck & Co. (Rahway, NJ)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), ...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good … more
- Merck & Co. (North Wales, PA)
- …by managementEducation Minimum Requirement: Bachelors degree with 1 year of clinical data management or standards experienceOrAssociates degree with 3 ... and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of...years of clinical data management or standards experienceOrHigh School/GED… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety , rights & wellbeing; data reliability; scientific ... line with established targets and including communication of updates Ensures proactive risk identification and mitigation planning for assigned clinical trial… more
- Insmed Incorporated (Bridgewater, NJ)
- …will be responsible globally for executing the safety and risk management activities for one or more clinical development or marketed products throughout ... the benefit- risk documents for assigned products and development compounds. Develops Safety Management Plans. Directs the compilation and interpretation of … more
- Merck & Co. (Rahway, NJ)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject… more
- Tris Pharma (Monmouth Junction, NJ)
- … reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams ... technical and leadership responsibility Current leadership and oversight experience for global safety activities, operations and risk management strategies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as ... and during post marketing. Serve as a bridge to Nonclinical Development on clinical safety findings, particularly ones likely to require additional nonclinical … more
- University Medical Center of El Paso (El Paso, TX)
- …management experience required. Strong clinical experience in patient safety , risk management or performance improvement required. ... to ensure compliance with regulatory agencies and ensure patient safety / risk management opportunities are properly...clinical processes. Promotes a culture to ensure that safety is perceived as a major factor, and proactively… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs ... in working in a fast-paced environment, continuous improvement, project management , change and risk management ....and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Merck & Co. (North Wales, PA)
- …including Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK/PD Modeling and Simulation organizations.Primary ... support of internal stakeholder groups including the Outcomes Research and Clinical Safety organizations.Lead and actively contribute to departmental strategic… more
- Merck & Co. (Rahway, NJ)
- …of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is ... systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine… more
- Merck & Co. (North Wales, PA)
- …of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is ... systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine… more
- Catalent (St. Petersburg, FL)
- …Process assessment, Method Validation, Bulk Mfg Protocol and Reports (non-GMP, Clinical , Registration, Process Validation, Product Transfer, etc.), Risk ... Assurance Department is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The Department has… more
- Aequor (San Diego, CA)
- …case and aggregate safety monitoring, safety reporting, contribution to benefit- risk assessment, risk management planning and strategy, and execution ... priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections. Ensure… more
- Merck & Co. (North Wales, PA)
- …of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position ... be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM… more
