- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and...key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams, ... for performing near real-time biosample tracking for the assigned studies in close collaboration with the QCP, Clinical...QCP, Clinical Biomarker Team, Companion Diagnostics, the Clinical Study Teams, Central & Specialty Laboratories,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at...Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG) across functional...cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify… more
- Merck & Co. (Rahway, NJ)
- …testing new systems, and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, ... we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating...and Process Guidelines. You will have the opportunity to lead and participate in the review of electronic case… more
- Eisai, Inc (Nutley, NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with...Provide oversight to eTMF system administration activities ( ie study set-up, country/site updates, user access, etc.) Triage and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- As a Clinical Study Lead (CSL),...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... NJ or Armonk, NY._ **A typical day as a Clinical Study Lead looks like:**...implement the operational strategic direction and guidance for respective clinical studies + A data driven approach… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Clinical Study Lead (CSL)...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... a Sr CSL looks like:** + Leads the cross-functional study team responsible for clinical study...implements the operational strategic direction and guidance for respective clinical studies + Demonstrates expert knowledge and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Clinical Study Associate Manager (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial ... sites may be required to assist with monitoring clinical studies . **A typical day might include...might include the following:** + Planning and running a clinical study in an assigned region(s) in… more
- Astellas Pharma (New York, NY)
- …regulations and guidelines from study start-up through to site closure. The Clinical Site Manager will manage the site/sponsor relationship as it relates to ... support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical ...(CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up… more
- Merck (Rahway, NJ)
- …+ May serve as the clinical trial team lead + May lead team in key study planning, development, and execution elements (eg, data management deliverables, ... (eg, study team, country teams, vendors, committees) in support of clinical study objectives. + Accountable for managing any study specific partners… more
- Pfizer (New York, NY)
- …etc.), and lead translation of pre- clinical observations into clinical experiments and studies designed to demonstrate proof of pharmacology, proof ... **ROLE SUMMARY** The Clinical Lead (CL), Internal Medicine RU...of clinical research plans into efficiently delivered studies . Creative in the conception of novel study… more
- Pfizer (New York, NY)
- … Scientist (CS) - Sr. Manager will support clinical epidemiology study execution for multiple studies for one or more vaccine programs. In collaboration ... Development and Life Cycle plans. Data generated by epidemiological studies is critical evidence needed to support clinical...clinical and operational content for clinical study reports and publications as appropriate. Lead … more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead sits within Clinical Development, ... and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of GOMA clinical activities as appropriate. **Responsibilities** _Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS)_ + Support the ... clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and...key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and… more
- Pfizer (New York, NY)
- …data set release and consistency in asset/submission data. **KEY RESPONSIBILITIES** + Serve as Clinical Data Scientist and Trial Lead for one or more clinical ... staff to deliver high quality data management for all studies as assigned + Proactively drives quality and efficiency...clinical trials and ability to assess and determine study requirement from protocol review + Strong Project and… more
- HSS (New York, NY)
- …IRB as well as execute needed patient renumeration and reporting of expense reports to study lead /director. + The Research Manager will be responsible for ... Mission, you too can be part of our transformation across the enterprise. Clinical Research Manager - Industry Full-Time Summary: This position compliments and… more
- Bristol Myers Squibb (Madison, NJ)
- … Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Will ... or more trials with the necessary supervision + May co- lead study team meetings in partnership with...the protocol in collaboration with Data Management/Programming + Submit clinical contributions to clinical study … more
