- Genmab (NJ)
- …Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data ... ultimate objective of data quality and consistency across programs and systems . Responsibilities Develops and implements company Study Data Tabulation Model (SDTM)… more
- Eisai, Inc (Durham, NC)
- …Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical ... and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing skills Experience… more
- Insmed Incorporated (San Diego, CA)
- …role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and efficiency ... builds using established standards and efficient processes in the implementation and integration of patient data systems ....Proven track record of leading EDC system design and implementation for clinical trials.Advanced proficiency in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual will be a key leader in ... role will support Compliance initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation … more
- Formation Bio (New York, NY)
- …development organization, there is a substantial component of oversight for the computer systems validation. The implementation of the QA strategy will involve ... guidelines, and preparing them for regulatory inspections. Overseeing the development, implementation , and upkeep of quality systems and procedures, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Merck & Co. (North Wales, PA)
- …responsible for the formulation and execution of automation strategy in Global Clinical Trial Operations and all the support activities within their functional area. ... This includes working with stakeholders across Global Clinical Trial Operations (GCTO)and other relevant teams, driving the strategy from ideation to value… more
- Insmed Incorporated (NJ)
- …This role will support implementation and ongoing management of digital systems used in clinical trial operations, quality control laboratories and other ... (CSV) and lifecycle management in clinical and/or laboratory environments.Knowledge of clinical systems (eg, EDC, IRT, eTMF, CTMS) and/or QC laboratory … more
- Merck & Co. (Rahway, NJ)
- …with employees at all levels to effectively engage and coordinate the implementation / readiness and execution of design verification tests and methodologies in ... and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …commitments, medical access programs.Partner with Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through ... QA, Development QA, and PVQA) to address GxP-related issues impacting clinical /medical access programs. Drive necessary change and efficiency through provision of… more
- Merck & Co. (North Wales, PA)
- …the guidance of an Executive Director, within the Value and Implementation , Outcomes Research the incumbent has the following responsibilities:1) development of ... developmental drugs and/or vaccines on a worldwide basis and3) development and implementation of Outcomes Research (OR) and Real World evidence programs to meet… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and enable flexibility and speed… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Principal Scientist/Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global ... payers, policymakers, health technology assessment (HTA)/reimbursement agencies and health systems globally.Types of studies executed include prospective and retrospective… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& Innovation Partner with appropriate departments to assist with the implementation and optimization of safety/quality/training systems Drive adoption of ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Patient Safety Operations. This role ensures that Safety/Quality/Training processes, systems , and resources are optimized to support regulatory compliance… 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 ... Health Canada. This individual also supports senior staff with required systems and process maintenance. Responsible for supporting the preparation, delivery,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and site-specific procedures.The position requires in-depth knowledge of ERP systems in a Manufacturing/Supply Chain environment, strong analytical and advanced ... various materials including (but not limited to) critical supplies, clinical materials, components and consumables.Develop, maintain and actively manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting and planning of drug supply needs. ... position also supports the management of the WO development and implementation .Supports packaging design and patient kit supply preparation, label generations and… more
- Aequor (Thousand Oaks, CA)
- …Training deliverables that support the Digital QMS Maintain knowledge of current systems , tools, standard methodologies, and terminology and ensure adherence to GxP ... System Regulations and Medical Device Standards Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and site-specific procedures.The position requires in-depth knowledge of ERP systems in a Manufacturing/Supply Chain environment, strong analytical, advanced Excel ... of various materials including (but not limited to) critical supplies, clinical materials, components and consumables.Participate in regular Site Supply Chain /… more
- Aequor (South San Francisco, CA)
- …Virtual 2. In-person Description The Translational Safety, Pathology team provides pre- clinical pathology assessments of risk. Within this group, the Digital ... Ideally, the candidate will also contribute to the development and implementation of new AI-powered image analysis algorithms and should have programming… more
