- Novo Nordisk Inc. (Plainsboro, NJ)
- …job skills: Experience in solution design, data management, data integration and database development techniques. Works in Agile solution delivery Experience in ... hard work and dedication with the opportunity for continuous learning and personal development . Are you ready to realize your potential? The Position The Senior… more
- Insmed Incorporated (Bridgewater, NJ)
- …Management activities including development of eCRFs, edit checks, coding, report development and database lock processes.Keep up to date on scientific and ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewTheDirector, Clinical Development will play an important role in working with the team to… more
- Merck & Co. (North Wales, PA)
- …limited to) the implementation of primary data collection, chart review/survey, database studies, health economic model development and adaptations, dossiers, ... including study execution through close-out of primary data collection, chart review, and database studies in addition to other activity types. Manages a variety of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThe Senior Paralegal, Intellectual Property and Business Development will manage and support various aspects of the company's ... enhancement. This role will assist with legal support for business development and alliance management projects and handle intellectual property projects, coordinate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will be responsible for managing ... transition of rising star early assets to late phase development , based on the vision for the functionAs the...conduct and oversight (study monitoring, tracking of clinical data), database lock, creating Clinical Study Report, and submission to… more
- Merck & Co. (North Wales, PA)
- …a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing, and marketing of medical drugs and… more
- Merck & Co. (North Wales, PA)
- …clinical projects.Primary activities: Serves as a statistical representative on Early Development Team of oncology programs and participates in strategic discussion ... of development plans. Develops individual protocols and statistical analysis plans...clinical trials, proposes solutions and carries them out.Participates in database design and medical monitoring meetings, to ensure that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As part of leading Regulatory Intelligence, this role will lead the development and implementation of a global approach (incl. processes, roles & responsibilities, ... information into actionable insights, as they relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant… more
- Merck & Co. (Rahway, NJ)
- …data integrity, security, copyright compliance, and precision and recall of the database . Leads end-user and system application development Participates in data ... end-users Collaborates with internal and external organizations in the development and integration of literature-related systems and information When necessary,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming ... and quality. Responsibilities include: contribute to CRF and SDTM standard development , support develop, implement, and maintain Analysis Data Model (ADaM) dataset… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path activities ... guidance of the study team leader and liaise with CRO to support interim analysis, database lock and review of TLG before and after database lock.Oversee CRO… more
- Merck & Co. (Durham, NC)
- …resolve problems that cross into inter-related units.Assisting in the identification, development , and implementation of new systems which enhances the operation ... Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.Must demonstrate strong leadership skills.Strong planning, scheduling, and… more
- Merck & Co. (Durham, NC)
- …resolve problems that cross into interrelated unitsAssisting in the identification, development , and implementation of new systems which enhances the operation ... electrical and instrument calibration.Experience with GMP-compliant calibration and/or maintenance database systems.Preferred Experience and Skills:Degree in industrial systems, Mechanical,… more
- Merck & Co. (Durham, NC)
- …information to Quality, Manufacturing, Process-Project EngineersAids in the development of SOPs, engineering change requests, preventative maintenance ... Office (Word, Excel and Outlook), Programmable Logic Controllers, Calibration/Maintenance Database SystemsStrategic leadership skills with principled and positive verbal… more
- Merck & Co. (Durham, NC)
- …resolve problems that cross into inter-related unitsAssisting in the identification, development , and implementation of new systems which enhances the operation ... the biopharmaceutical fieldExperience with GMP compliant calibration and/or maintenance database systems.Knowledge of SAP and DeltaV and Procal.Physical Requirements:… more
- Aequor (South San Francisco, CA)
- …execution of PK studies of molecule characterization as well as preclinical models development to determine the PK and metabolic fate of our candidate therapeutics. ... and external collaborators. The role will include PK data analysis, database entry/updates, and study/data reporting. Team interactions, and department presentations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents ... under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path activities and ... leader and liaise with CRO to support interim analysis, database lock and review of TLG before and after... lock and review of TLG before and after database lock.Oversee CRO study close-out activities (including but not… more
- Merck & Co. (Rahway, NJ)
- …the role of Associate Director. The team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... Directors are emerging leaders in the field of quantitative drug development , with a developing understanding of the strategic elements of drug… more
- Merck & Co. (Rahway, NJ)
- …activities for multiple and/or large/complex late stage drug/vaccine clinical development projects.- Accountability predominantly includes the development and ... statistical databases that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation.The position is a key… more
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