- 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
- Merck & Co. (Rahway, NJ)
- …, biomarker data , and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.- ... creates and ensures the successful execution of the clinical data management strategy for assigned trials...guidance of more senior staff, may serve as the data management lead or perform a support… 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)
- …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)
- …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
- 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... 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
- 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… 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
- Sanofi Group (Trenton, NJ)
- …and strategy plans to RSM/GSM. **Key Internal/External Relationships:** **INTERNAL:** + Clinical Research Operations Manager (CROM) or equivalent (eg, Team ... risks assessment in processes, vendors services and resources + Lead Country Study Set up to ensure progress according...targets within agreed timelines. + Aligns with Site Partnership Manager (SPM) on activities to engage with sites: calls… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead sits within Clinical Development, ... and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key...following attributes: + Able to synthesize internal and external data to produce a clinical strategy +… more
- Bristol Myers Squibb (Princeton, NJ)
- …and CRA training materials and present these at SIVs and Investigator meetings + Review clinical narratives + Monitor clinical data for specific trends + ... activities associated with the conduct + May serve as Clinical Trial Lead for one or more...collection in alignment with the protocol in collaboration with Data Management/Programming + Submit clinical contributions to… more
