- Novo Nordisk Inc. (Plainsboro, NJ)
- …resolutions, and trends Collaborate with other departments to develop and implement risk mitigation strategies Lead the development and implementation of ... The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four functional areas: Policies &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... supports oversight and management of integrations solution design, implementation strategy...for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the US, in collaboration with the Global RD/PV QA team.RESPONSIBLITIESProgram oversight : Support the Global Quality Lead (s) (GQLs) and Regional Quality ... data may be shared with the relevant business functions teams within the DS organization. Risk -based Quality Oversight . Contribute to the measurement of DS KPIs /… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated...according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project or equivalent. Lead the creation of the cross-functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take ... and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead ...plan and milestones (eg protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.). The study team leader will ensure… more
- Aequor (South San Francisco, CA)
- …associated risk mitigation and control strategies, provide processes and tools for oversight of the overall risk and issues management, and offer continuous ... ultimate goal of driving data-driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data Analyst sits in the Data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role will be responsible for all aspects of clinical trial management and oversight of trial teams. Relationships This position reports to the Director, Clinical ... use efficient project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk...other functions (at CRO or internally) to ensure robust oversight for study level data review, including trend evaluation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues supporting Global Medical Safety Lead . Responsible for safety governance/ oversight of Clinical Safety and risk management activities. Providing ... immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for overseeing the health of the manufacturing processes. This starts with proper risk analysis in manufacturing design, then goes into addressing risk in ... as directed by the Quality Manager. In addition, the Quality Engineer will lead continuous improvement efforts following a structured methodology such as six sigma.… more