- 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
- Merck & Co. (North Wales, PA)
- …for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable for overseeing the ... research division QA and acting as the link between Clinical Development, study teams, global business functions...of the quality management system are in place for studies conducted in partnership with non-commercial organizations (eg NGO,… more
- Merck & Co. (North Wales, PA)
- …related study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data ... clinical trials.Required Skills: Adaptability, Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, … 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
- 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
- J&J Family of Companies (Spring House, PA)
- …of America **Job Description:** Johnson & Johnson Innovative Medicine is currently seeking a Senior Manager of Clinical Development in North America and to ... alter the course of cancer and improve survival. The Senior Manager of Clinical Development...conduct . Participate in the development & execution of study operational plans . Collaborate with individuals and groups… 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
- 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
- Merck (West Point, PA)
- …the operational/executional arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and ... operational plans for all activities associated with clinical supplies for their assigned studies , which...+ Responsible and accountable for establishing the timelines for clinical supply needs per study and providing… more
- Merck (North Wales, PA)
- …and follow up of regulatory inspections. **Operational Quality Management:** + The Clinical Quality Operations Manager is accountable for overseeing the ... research division QA and acting as the link between Clinical Development, study teams, global business functions...of the quality management system are in place for studies conducted in partnership with non-commercial organizations (eg NGO,… 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good ... throughout the clinical development lifecycle. **Key Responsibilities** ** Clinical Study Support** + Serve as a...+ Monitor audit trends and escalate recurring issues to senior leadership. **Quality Systems & Compliance** + Support the… more
- Kelly Services (West Point, PA)
- ** Senior Study Manager I**...Immunology** **Description of Services** May lead or support a study or studies , depending on size/complexity. As ... change orders for vendors, as necessary + Responsible for end of study reconciliation ( clinical & ancillary supplies) + Oversees all HQ close-out tasks +… more
