- 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)
- …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)
- …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)
- …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
- Eisai, Inc (Nutley, NJ)
- …to evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides… 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)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesManage ... centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of... data review listings and reports to support Data Management and clinical teams.Develop, implement and… 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)
- …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)
- …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)
- …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)
- …ensure high data quality and proactive detection and resolution of issues. Lead effective communications within the GPT, by interacting with other GxP QA ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …place in accordance with the RSEM and local country teams.Partner with TMF lead and CRO Oversight leaders to ensure CRAs are updating appropriate systems.Ability to ... analyzes data /metrics/key performance indicators to support vendor/CRO oversight of CRAs...performance indicators to support vendor/CRO oversight of CRAs in clinical trials.Provide direction to Alliance and CRO CRA leadership… 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
- EY (New York, NY)
- …personalities Strong verbal and written communication skillsAbility to learn the science and clinical trial data on brands you'll be responsible for working ... needed and collaboration with the Content Factory Content Library lead to make sure all content is tagged for...society and build trust in the capital markets.Enabled by data and technology, diverse EY teams in over 150… 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
- 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
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Clinical Lead (CL), Internal Medicine RU (IMRU) will be the thought leader driving clinical research for the expanding area of metabolic ... and the highest ethical standards. He or she will lead clinical development strategy and program execution...deep medical and clinical knowledge to translate clinical research ideas into high-quality decision-making data ,… more
- Actalent (Bernardsville, NJ)
- Description: As a Clinical Study Lead (CSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical ... CROs + Leads the cross-functional study team responsible for clinical study delivery and is the primary point of...including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project… more
