- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...to process standards and tools to achieve excellence in trial operations and management .Monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ... and execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting...Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall drug development ... around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label Development process which includes ... Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling...Qualifications7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or… 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 R&D IT...validation or user acceptance testing, and integrations with other clinical applications through change management . Maintains the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Axelon Services Corporation (Princeton, NJ)
- …strategies within a specific therapeutic area(s) and is accountable to support clinical trial vendor partnerships across select or multiple service categories ... Job Description: Position Summary Outsourcing Management Hybrid Schedule The candidate must be able...of clinical trial activities in R&D. Key Responsibilities:… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...to process standards and tools to achieve excellence in trial operations and management .Monitor and ensure compliance… more
- AbbVie (New York, NY)
- …a framework required by the FDA for all clinical studies (PhIII) to improve clinical trial diversity. With this role, you will be an important member of the ... that enable equitable trial access and enhanced trial experiences. The Senior Manager within the...our understanding of disease disparities and the effects on clinical trial populations. This role will report… more
- Merck (Rahway, NJ)
- …(CRF) data, lab data, biomarker data, and patient reported outcomes. + Serve as project manager of all clinical data management activities for trials as ... team is recruiting for summer interns within the trial manager area of our company. The...clinical data management perspective. + Provide clinical data management input into trial… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr. Manager , Clinical Advisors Date: Aug 27, 2024...groups and health systems. + Drive the analysis of clinical trial data, prepare and report trial ... on medical and scientific questions/issues during trial follow-up phase). + Review CEC/DMC/ Clinical trial reports. + Provide medical- clinical trial … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) ... etc. + Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...vendor management + Advanced technical proficiency in trial management systems and MS applications including… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) ... etc. + Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...vendor management experience + Technical proficiency in trial management systems and MS applications including… more
- Bristol Myers Squibb (Madison, NJ)
- …Summary / Objective** + Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members ... activities associated with the conduct + May serve as Clinical Trial Lead for one or more...with instruction + Provide regular and timely updates to manager / management as requested + Develop Protocol and… more
- The Mount Sinai Health System (New York, NY)
- … Trials Manager , you will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated ... the Tisch Cancer Institute. **RESPONSIBILITIES** + Manages and coordinates clinical trial and related research studies conducted...field; Masters preferred + 6+ years of experience managing clinical trials, including 2 years in a management… more
- AbbVie (Branchburg, NJ)
- …Trial Team(s) + Managing the project-related clinical development budget with the Clinical Trial Team and Project Manager + Ensuring that decisions ... outlined in the Growth Product Flow model, including Life-cycle management . The CTL fosters an atmosphere of collaboration, mutual...responsible for: + Ensuring alignment between the IEST, and Clinical Trial Team(s) + Developing the proposed… more
- Abbott (New York, NY)
- …initiatives. The Clinical Lead Specialist is to support Abbott TAVI US clinical trial and commercial case coverage, trial enrollment and sales ... in collaboration with the Regional Sales Directors and the Clinical Lead Manager (CLM). This position will...proper patient selection. + Serving as primary resource for clinical trial and lead/coach/commercial case support, demonstrating… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …who have vendor management experience, as well as experience in clinical trial operations including developing key study documents. We also require ... Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to...someone who has technical proficiency in trial management systems, Microsoft applications and TMF,… more
- Vitalief (New Brunswick, NJ)
- …is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities. + Performs prospective reimbursement analysis according ... institutions, sponsors, attorneys, governmental agencies, and principal investigators. + Requests clinical trial budgets and contracts documents from sponsors… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists with and may author/review ... The Senior Manager , Hematology, Clinical Scientist leads in...process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical trial process improvements. Considerable organizational awareness,… more
