- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... Biostatistics and Data Management Data Operations team and serves both as a subject matter expert and leader of a group responsible for the business… more
- Merck & Co. (Rahway, NJ)
- …cycle, budget preparation and overall accounting knowledge. Thorough understanding of data manager packages. Strong understanding of Enterprise Process ... provide operations solutions reviewing and analyzing system and passive data governance reports to ensure high quality data... data governance reports to ensure high quality data and timely and complete synchronization between systems. Acts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development ... Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... both technical & business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... business risks, & influence portfolio decisions with facts and data - Demonstrates ability to balance strategy with ability...Analytical & Problem Solving Skills: ability to analyze complex data , identify trends, and make data -driven decisions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology department of the Global Precision Medicine function. The Manager , CDx Diagnostics Scientist's primary responsibilities are:Assists in defining the ... assessment and implementation plan for clinical trials.Executes biomarker testing and data capture at central and analytical labs for clinical trials. Supports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Scientist Lead and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals, track safety signals in ... Investigator's Brochure, aggregate reports (DSUR/PLL), prescribing information, Company Core Data Sheet (CCDS), Risk Management Plans (RMPs).Contributes to regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Scientist Lead and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals, tracks safety signals in ... Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing Information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs).Contributes to regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Scientist Lead and PSL or Clinical Safety Physician(s) to evaluate safety data of any source to identify potential safety signals, tracks safety signals in ... Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing Information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)Contributes to regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, ... (eg, Executive Committee). Provides input to Clinical Operations on monitoring plan (eg data fields to be SDV'd) and to Biostatistics on Statistical Analysis Plan… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the United States, Japan, and Europe, as applicable, to gather and generate the data required for the development of relevant quality reports and outputs (JOC, QRB, ... the supervision of the IMT Lead.Management Review: Collect the data and information needed to ensure oversight of ongoing...Quality Events (QEs), audit, and inspection outcomes so these data may be shared with the relevant business functions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across...Gen AI security and governance policies to ensure that data is collected, managed, and used in a responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development ... Experience with CRO contracts preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in… more
- Merck & Co. (Rahway, NJ)
- …scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. The incumbent will be ... within the framework of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and mentoring organizational leaders in… more
- Merck & Co. (Rahway, NJ)
- …to ensure proper use of trademarks and facilitate document legalizationReview data discrepancy reports, gather specified information and/or documents, and submit ... in the pharmaceutical or healthcare industryExperience with Thomson IP Manager (TIPMS)Experience with CorsearchCurrent Employees apply HERE Current Contingent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... contracts, assessing security and technical provisions. Advises on issues related to data privacy, data management and Artificial Intelligence. Develops contract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company. [Specific assignments to be determined by direct manager of the role.Creates, implements, and presents training programs and materials on ... Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, state and federal data privacy laws, and product liability laws) required7 or More Years pharmaceutical… more
- New York Edge (Queens, NY)
- Summary: Under the direction of the Data Manager , the Assistant Data Manager will collaborate on multiple year-round projects to meet the organization's ... Survey outcomes, EMT analysis, Program Summary Report, etc. In conjunction with Data Manager oversight, the Assistant Data Manager will supervise… more
- The Research Foundation SUNY Downstate (Brooklyn, NY)
- Data Manager ANNOUNCEMENT OF PROFESSIONAL VACANCY Applications are invited for consideration to the following position Department: Psychiatry Budget Title: ... Data Manager Salary Range: (Based Upon Experience)$70,000.00 - $100,000.00 Descriptive Title: Data Manager Full-time, Monday to Friday, 9:00am - 5:00pm,… more
- RWJBarnabas Health (Jersey City, NJ)
- Clinical Data Manager (RN) Department of Surgery Full Time DayReq #:0000189763 Category:Nursing Status:Full-Time Shift:Day Facility:Jersey City Medical Center ... etc. Other Duties: The responsibility of the Trauma Registrar/Registry Clinical Data Manager RN is to ensure the Trauma Registry contains accurate, detailed,… more
