- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports).Leads ... diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...minimum of 2 years of direct expertise of site management and logistical execution of clinical trials… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Provides tactical leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan.… 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 ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across CMR to plan, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... review, Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical device, ... employer including veterans and people with disabilities. Summary The Manager External Data Management , is..., is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Indicator (KPI) data received from Global Safety to Patient Safety Management Responsible for timely review and preparation of Quality Management Review ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … stewardship and governance processes, data cataloging data standards, data quality, and data management .- Develop and implement strategies for ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work...program, data stewardship program or similar intent data management program focused on setting standards,… 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 ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including experience in one or more key functions (eg, clinical research, clinical operations, data management , biostatistics, project management ) ... research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …negotiation, preparation, and execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and ... management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ability… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... Are you ready to experiment with us? The Position The Consumer Strategist Manager will be a critical driver in shaping an insights-driven Consumer marketing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on a regular basis. Collaborates with other cross-functional representatives to ensure data is available to process owners.Change Management : Collaborates with ... and immune disorders. Summary The Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports process improvement project… more
- Tris Pharma (Monmouth Junction, NJ)
- …portfolio of best-in-class ADHD medicines and an exciting pipeline of clinical -stage programs across Pain, Psychiatry, and Neurology. Our proprietary technologies ... an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior Manager , Business… more
