- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …Clinical Outsourcing Team in Princeton, NJ. The Senior Manager , Clinical Outsourcing will report into Sr . Director, Clinical Outsourcing. Under ... **Title:** Senior Manager , Clinical Outsourcing...have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sites +… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: The Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with ... with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in adherence to Good… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of… more
- Parexel (Trenton, NJ)
- …for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies , in compliance with Client Procedural Documents, international ... **CRA and Sr CRA positions- Remote - Need for SE...escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance… more
- Novo Nordisk Inc. (New York, NY)
- …NNI and competitor products Demonstrates thorough knowledge of all promoted NNI approved clinical studies and the skill to engage customers (prescribers, support ... current co-promotion partners. Internally, the CMCS I reports to the District Business Manager of the specific sales territory. The CMCS I also interacts and… more
- Parexel (Trenton, NJ)
- **Job Purpose:** The Senior Clinical Research Associate ( Sr . CRA) is responsible for the site management, site monitoring and close-out of assigned ... Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, Recruitment Specialist, Clinical Data Scientist) +… more
- Parexel (Trenton, NJ)
- The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in ... for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies , in compliance with Client Procedural Documents, international… more
- Parexel (Trenton, NJ)
- …management activities **CSR Narratives (as applicable)** + Performing medical review of Clinical study report narratives according to the client's guidelines and ... and sign off adverse events report for accuracy and clinical importance, relationship to the study drug...processing cycle + Provide input as necessary to Feasibility Studies , Data Monitoring Committees (DMCs), Clinical Endpoint… more
- Parexel (Trenton, NJ)
- …investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical ... **Job Summary:** The Senior Medical Writer will research, create, and edit...skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study … more
- Parexel (Trenton, NJ)
- …Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project ... contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training… more
- Parexel (Trenton, NJ)
- …assigned project/ study . + Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), ... Supporting Activities - Medical Support / Medical Monitoring for projects and studies contracted to Parexel - Deliver all medical support required for successful… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …necessary to design and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a typical day may include the ... The Senior Manager , Hematology, Clinical Scientist...and interpretation of study data of a clinical development program. The Sr . Manager … more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Job Title:** Senior Manager - Analytical AI, Clinical Development **Job ... advance clinical development through data-driven innovation, the Senior Manager - Analytical AI in ...optimize end-to-end pipelines that address critical business problems in clinical study design and execution. + Automate… more
- IQVIA (New York, NY)
- …Clinical Data Management role. + Your previous roles/job titles may include _Clinical Data Manager , Senior Clinical Data Manager , Lead Data Manager ... now and have your resume considered for Lead Data Manager opportunities across multiple teams - allowing us to...You'll Do** + Lead data management for complex, global clinical trials from study setup to database… more
- Philips (Mercerville, NJ)
- ** Clinical Study Manager , Computed Tomography (EST Time zone)** The Clinical Study Manager will be responsible for the execution and regulatory ... compliance of clinical studies for our Computed Tomography business....conducts trend analysis for risk mitigation, and delivers timely study updates and recommendations to leadership and senior… more
- Taiho Oncology (Princeton, NJ)
- …complex global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical ... and monitor trial milestones as well as overall day-to-day operations of clinical studies , ensuring study information and timelines are accurate in internal… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The ** Senior Clinical Study Lead**...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... in this role 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
- Pfizer (New York, NY)
- …groups to ensure study teams are enabled to implement eCOA in clinical studies efficiently, consistently and with the highest quality and lowest regulatory ... the Clinical Development &Operations (CD&O) organization, the Senior Associate, eCOA Manager , Clinical ...of the Patient Data Strategies (PDS) team in helping clinical study teams use assigned patient data… more
- Bristol Myers Squibb (Princeton, NJ)
- …and execution of multiple clinical trials (eg significant experience as a senior clinical leader), and exhibits all of the following attributes: + Able ... 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
- Mount Sinai Health System (New York, NY)
- …of the Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, ... **Job Description** Under minimal supervision, coordinates the clinical assessments of the study subjects;...genetic tests. 7. Independently obtains informed consent for other clinical studies . 8. Mentors Clinical … more
