- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring ) sets the vision and strategy for the RBQM function within R&D. Reviews ... partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety signal ... trial safety data. Lead the statistical support for safety signal monitoring for ongoing trials.Safety analysis methodology and standardization, develop and support… more
- Merck & Co. (North Wales, PA)
- …as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations ... assessments, biomarker sample collection and management, and external data monitoring committee.Managing other scientists directly supporting the clinical trialCurrent… more
- Aequor (Thousand Oaks, CA)
- …and Quality Control operations. Under minimal supervision analyze environmental monitoring samples, cross check sample requirements against SOPs and enter ... results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position will work in a team environment, collaborating within the lab as well as with various colleagues in the network. Key Responsibilities: At all times, align with… more
- Twist BioScience (South San Francisco, CA)
- …cloud-based or on-prem environments.Collaborate with DevOps teams to maintain monitoring , logging, and alerting systems for pipeline reliability and ... CI/CD, and cloud platforms (AWS, GCP, or Azure).Experience with monitoring , logging, and alerting tools for bioinformatics workflows.Cross-Functional Collaboration &… more
- Twist BioScience (South San Francisco, CA)
- …system performance, availability, and audit readiness through proactive monitoring and maintenance.Cross-Functional Collaboration: Partner closely with the platform ... and CSV.Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting… more
- Aequor (West Greenwich, RI)
- …collection and sample handling to support GMP operations and Environmental/Water monitoring . 2. Perform testing and possible data review for compendia, non-compendia ... methods, and routine laboratory procedures. 3. Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and maintain specialized laboratory equipment and instrumentation. 5. Participate in… more
- Repligen (Waltham, MA)
- …to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and report on monthly supplier performance ... data, including quality, delivery, and service metrics.Prepare and distribute supplier report cards in a standardized format to internal stakeholders and suppliers.Maintain and update monthly supplier statistics to monitor trends and identify areas for… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, initiation, execution,- monitoring , analysis, regulatory reporting, publication, and presentation at national ... and international meeting.- He/she will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. Specifically, the Senior Director May Be Responsible For: Evaluating… more
- Shimadzu Scientific Instruments (Chicago, IL)
- …suppliers of analytical instrumentation, physical testing, and environmental monitoring systems in the world. Ground-breaking scientific research, manufacturing ... ideas and results continue to propel Shimazu's outstanding reputation and "Excellence in Science." People dedicated to our mission have the largest impact on Shimadzu's continued growth and success. Would YOU like to join a diverse team of professionals… more
- Merck & Co. (Rahway, NJ)
- …role will develop a plan to-utilize-data visualization, data analysis, data monitoring and data modeling-to enable better business decisions.-Through analysis of ... equipment history, process data, operating procedures and Failure Modes Effect Analysis and many other data streams, the incumbent-will-integrate-statistical data into visual-dashboards-information into insight and business decisions.Primary… more
- Genmab (NJ)
- …in definition, review, and approval of data packages for Data Monitoring CommitteesReview and approve any amendments, corrections, and updates of data ... packagesSupport regulatory submission/filing activitiesExperience:Master's or PhD in a statistical discipline8+ years of experience in relevant area preferred, or demonstrated capabilityExperience in statistical analysis, modelling and simulation and adaptive… more
- Eisai, Inc (Nutley, NJ)
- …preparation and follow-up (eg Informed Consent Form, eTMF fling plan, Co- Monitoring Plan)Creates Clinical Trial Agreement requests using the legal tracker and ... to Epic siteCoordinates reviews for essential materials such as ICFs and Co- monitoring plans CRO and Vendor Contributions: Assist in managing ancillary supplies with… more
- Merck & Co. (WY)
- …Healthcare Sales, Lead Generation, Managed Care, Market Analysis, Marketing, Monitoring Control, People Leadership, Pharmaceutical Sales, Product Knowledge, Resource ... Allocation, Sales Forecasting {+ 4 more}-Preferred Skills:Job Posting End Date:08/5/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the… more
- Shimadzu Scientific Instruments (Minneapolis, MN)
- …suppliers of analytical instrumentation, physical testing, and environmental monitoring systems in the world. Ground-breaking scientific research, manufacturing ... ideas and results continue to propel Shimazu's outstanding reputation and "Excellence in Science." People dedicated to our mission have the largest impact on Shimadzu's continued growth and success. Would YOU like to join a diverse team of professionals… more
- Merck & Co. (Rahway, NJ)
- …include:Project support for System Development, Maintenance, Enhancement and System Monitoring related initiatives.Serve as a liaison between the Global Labeling ... Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs.Facilitate System Operations Mtgs including discussions to resolve issues and manage competing… more
- Merck & Co. (Rahway, NJ)
- …entire cycle of clinical development, including study design, placement, monitoring , analysis, regulatory reporting, and publication.Specifically, the Director may ... be responsible for:Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applicationsDeveloping of clinical development strategies for investigational or marketed Oncology… more
- Lundbeck (Dallas, TX)
- …Ensures business planning execution by the regional sales team via monitoring /reporting sales performance against key performance metrics. Adjusts metrics/targets as ... appropriate. Utilizes reports and other approaches to conduct business reviews and coaching and maintain highest levels of overall sales performance to desired objectives. Partners with Alliance partners to develop integrated strategic business plans and to… more
- Aequor (Tampa, FL)
- …raw materials, finished products, and stability samples. Perform environmental monitoring which includes water sampling and testing. Performs microbiology methods ... and sampling techniques. Performs investigations and completes CAPA in response to laboratory investigations. Manages change controls effectively. Manages/ supports microbiology projects from production or formulations development dept. Actively participates… more
- Merck & Co. (Rahway, NJ)
- …the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data/medical protocol deviations in ... collaborations with the Clinical Director. Other responsibilities include: Collaborating cross-functionally in the development of Protocol and related study materials (e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables.… more
