- Actalent (Morristown, NJ)
- …100% of their drug candidates are invented and developed in house! Description: + Clinical Data Manager who will work collaboratively with vendor Project ... tasks for assigned study. + Coordinate, lead and perform clinical data management activities for... management functions. Manage coordination of CRO data manager and project team to ensure… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Functional Expertise: + Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports). + Leads and ... diseases and immune disorders. **Summary** Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of CDISC and SDTM and industry standard data collection practices. + Clinical data management experience in a medical device, pharmaceutical company, ... employer including veterans and people with disabilities. **Summary** The Manager External Data Management , is..., is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part ... The Senior Manager , Hematology, 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)
- …and ensures scientific integrity and interpretation of study data of a clinical development program. The Senior Manager reports to the Director, Clinical ... We are seeking a **Senior Manager , Clinical Sciences** to lead in... data analysis + Promoting 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
- 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...implement the operational strategic direction and guidance for respective clinical studies + A data driven approach… 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...with commercial group regarding new indications for Life Cycle Management . + Additional non-study related activities: Clinical … more
- IQVIA (Bridgewater, NJ)
- …quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. * Manage clinical ... internal and external stakeholders through effective communication and resolution management . * Collaborate with the clinical team...believe in pushing the boundaries of human science and data science to make the biggest impact possible -… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... review, Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review… more
- Fresenius Medical Center (Phillipsburg, NJ)
- **About this role:** As a Clinical Manager with Fresenius Medical Care, you will ensure that quality patient care is delivered while maintaining clinical ... functions, leading your business, and advanced leadership. As a Clinical Manager , you may advance your career...of medical and operations records and complies with all data collections and auditing activities. + Accountable for completion… more
- IQVIA (Warren, NJ)
- … is behind the creation and implementation of various initiatives (including CHIP). The Data Management Principal Program Manager of Quality and Governance ... patient outcomes. IQVIA is the leading global provider of data , advanced analytics, technology solutions and clinical ... research services for the life sciences industry. _The Data Management team is a part of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- *We have 2 open roles for this job. We are looking for a Manager Global Procurement- Clinical who will be responsible to support and assist in the development and ... structure, manages teams of professional level employees responsible for performing category management tasks (if applicable.) + Uses data to drive… more
- Bausch Health (Bridgewater, NJ)
- … management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management . * Minimum 6 - 8 years' ... Clinical Operations. May supervise direct/indirect reports including Clinical Trial Manager (CTM), Senior Clinical...of the events to the ECs/IRBs + Liaise with Data Management to review data … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc. + ... based in Armonk, NY or Basking Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports...as CSAM looks like:** + Lead/oversee the planning and management of a clinical study in an… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …SDTM and industry standard data collection practices preferred - 7+ years Clinical data management experience in a medical device, pharmaceutical ... team as an extended part of committee. Advise Study Data Manager on complex vendor management...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …data stewardship and governance processes, data cataloging data standards, data quality, and data management . - Develop and implement strategies ... centered around rare diseases and immune disorders. **Summary** The Manager of Data Governance Stewardship will work...program, data stewardship program or similar intent data management program focused on setting standards,… more
- J&J Family of Companies (Raritan, NJ)
- …executed clinical studies, for the supported franchises delivering high quality clinical data to support Regulatory, Market Access, Reimbursement and Market ... * Provide internal communication to key stakeholders of important clinical data and events (inc. * escalation...is highly preferred * Minimum of 5 years people management experience including Manager level FTEs is… 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
- ThermoFisher Scientific (Bridgewater, NJ)
- …using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to ... Impactful Work:** Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts...trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures… more