- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …an innovative RNAi technology platform. The CPM will be responsible for all aspects of clinical trial management aimed at treating a rare or infectious ... development experience in the pharmaceutical industry Minimum 2 years of experience as a Clinical Trial /Project Manager Experience with global clinical … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential?… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may include MA management , MA project management , Medical Communications, Clinical Trial Management , Clinical Development and Outcomes Research ... Affairs interests on cross-functional teams including, Field Medical Affairs, Medical Operations, Clinical Trial Management , HEOR, Market Access, Marketing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management , and Clinical Development. ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations.… 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
- 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
- Astellas Pharma (New York, NY)
- …support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and ... sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures...data and essential documents in relevant systems used for trial management . + Fully documents trial… more
- Novo Nordisk (Plainsboro, NJ)
- …an innovative RNAi technology platform. The CPM will be responsible for all aspects of clinical trial management aimed at treating a rare or infectious ... budget review and forecasting + Independently manage interactions with clinical monitors, data management , safety, regulatory, pharmaceutical...industry + Minimum 2 years of experience as a Clinical Trial /Project Manager + Experience… 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
