- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Collaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential ... surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …alignment on key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership with ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… 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 ... EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical...before database lock; collaborates with lead statistician on SAP update, as needed. Provides input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical… 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)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG)...management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a ... team as an extended part of committee. Advise Study Data Manager on complex vendor management issues...standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... In this key role, the candidate will have to lead a complex, global team in charge of a...a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry expertise and...including experience in one or more key functions (eg, clinical research, clinical operations, data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analyses or consulting experience. required andPrior work experience as a project manager , project lead , or similar role within pharmaceutical drug development ... and immune disorders. Summary The Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports process improvement project… 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)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… 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
- Merck & Co. (North Wales, PA)
- …trial scientific-activities.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical ... set up) Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical … more
- Lundbeck (New York, NY)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the...Ability to use digital tools and apply customer and data -based insights to build opportunities, develop strategy & tactics… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- As a Clinical Study Lead (CSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from ... NJ or Armonk, NY._ **A typical day as a Clinical Study Lead looks like:** + Leads...implement the operational strategic direction and guidance for respective clinical studies + A data driven approach… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Clinical Study Lead ** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large ... clinical studies + Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving...awareness of relevant industry trends + Ability to build, lead and develop productive study teams and collaborations +… more
- Actalent (Basking Ridge, NJ)
- Description: + Clinical Data Manager who...data management tasks for assigned study. + Coordinate, lead and perform clinical data ... will work collaboratively with vendor Project Managers and Clinical Data Managers to assure that ... data management functions. Manage coordination of CRO data manager and project team to ensure… more
- IQVIA (Bridgewater, NJ)
- …teams to improve patients' lives by bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core project team responsible for ... out of scope work. * Work as the primary Clinical Lead alongside other Clinical ...believe in pushing the boundaries of human science and data science to make the biggest impact possible -… more
