- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summar y : The Manager , Data Management is accountable for end-to-end delivery of clinical data management ... of assigned studies. This position requires a strong working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are ... Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Eisai, Inc (Nutley, NJ)
- …the programming team in terms of application design, development, validationGood understanding in Clinical Data Management Systems & standards, eg, InForm, ... relational Databases, Oracle, SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ability to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management , Statistics). This position ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- …Travel Requirements: Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills: Data Management , Data Science, ... President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction… more
- Novo Nordisk Inc. (Saddle Brook, NJ)
- …relationships with those individuals Recognize opportunities to productively challenge HCPs clinical management of patients that respects their knowledge and ... maintain advocacy of customers aligned to company, brand and clinical goals. The OCS develops local strategies and executes...health. Internally, the OCS reports to the District Business Manager of the specific sales territory. The OCS also… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... annual speaker re-contractingUpdate and track KOL engagements via Veeva/Vector KOL management platformCollaborate appropriately with other Field teams to enable the… more
- Bristol Myers Squibb (Madison, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager , Clinical Data Management is a leadership role ... and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data … more
- J&J Family of Companies (Somerville, NJ)
- …**Job Function:** Data Analytics & Computational Sciences **Job Sub** **Function:** Clinical Data Management **Job Category:** Professional **All Job ... to wellness. Learn more at https://www.jnj.com/medtech **OVERALL RESPONSIBILITIES:** The Manager , Data management , will be...oversight and management of all aspects of clinical data management associated with… more
- Deloitte (Morristown, NJ)
- …serve + Limited immigration sponsorship may be available Preferred: + Techno-functional knowledge of clinical data flow, data architecture, and data ... Experience with solutions for data -driven trials and clinical development insights (ie: site burden, patient burden, study... data architectures is important. This includes multimodal data management , model design, Data … more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Clinical Risk Manager in the Department of Risk Management and Patient Safety is responsible for the day to day risk management ... Sinai Health System, including investigating, managing and analyzing risk management data ; complying with risk management...and conducting risk management educational programs. The Clinical Risk Manager is responsible for the… more
- RWJBarnabas Health (West Orange, NJ)
- …and output quality, Manager will also support gathering and organizing data from a variety of clinical sources, including retrospective and concurrent ... Quality Clinical Abstractor Manager - West Orange, NJReq... Manager - West Orange, NJReq #:0000204455 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health Corporate Services Department:Quality Resource… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Manager Clinical Study Lead** (CSL **)** may perform the following responsibilities with moderate oversight: accountable for the global execution of ... including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master… more
- Mount Sinai Health System (New York, NY)
- …in key areas such as protocol review, patient interactions, regulatory documentation, and data management . + Ensure new staff understand and follow Standard ... **Job Description** The **Project Manager II** will oversee the entire portfolio of...management , and team leadership. + Progressive managerial and clinical job related experience specific to area of responsibility.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … studies and ensures integrity and interpretation of study data of a clinical development program. The Senior Manager leads in a matrix environment as part ... The Senior Manager , Oncology, Clinical Scientist leads in...critical risks and mitigations + Promotes consistent first line medical/ clinical data review techniques and conventions across… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific ... maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master...clinical studies + Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Project Quality Manager **Location:** Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on to ... lead GCP Clinical Inspection Readiness (IR) activities via a project management approach and to contribute to the implementation of integrated and comprehensive … more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Clinical Program Manager provides clinical support and administrative direction within the Tisch Cancer Institute's Clinical ... Trials Office (TCI CCTO). In collaboration with the disease management team, clinical trials investigators, and TCI...the administration and plan of the research program. The Clinical Program Manager will report into the… more
