- 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
- 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
- Integra LifeSciences (Trenton, NJ)
- …Contributes to achievement of departmental goals and operating plans + Authors clinical study reports, manuscripts for publication, posters, abstracts or ... to advance patient outcomes and set new standards of care. The **Associate Manager , Medical Writing** is a senior level professional with advanced knowledge… 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
- Taiho Oncology (Princeton, NJ)
- …to transforming the landscape of cancer treatment and improving patients' lives. As a Senior Manager , Clinical Research Scientist, you will play a pivotal ... at the forefront of cancer research. Position Summary: The Senior Manager , Clinical Research Scientist...conferences and leverages the knowledge for designing and summarizing clinical studies . + Keeps Sr .… 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
- 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
- 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
- Taiho Oncology (Princeton, NJ)
- … documents related to clinical studies as outlined by the manager . + Attend study site initiation visits (SIV) and provides therapeutic area, compound, ... (IB), informed consent forms (ICF), case report forms (CRF), Clinical study report (CSR), NDA/MAA registration documents,...Institutional Review Boards/ Ethics Committees (IRBs/ECs) relevant to the studies . + Review and sign off on clinical… more
- Taiho Oncology (Princeton, NJ)
- …standards and guidance documents + Serve as regulatory lead for assigned activities and clinical study teams. + Provide updates to project/ study teams on ... Hybrid Employee Value Proposition: Join our dynamic and expanding mid-size company as a Sr . Manager , Regulatory Affairs Strategy. In this role, you will support… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Embark on a transformative journey with Taiho Oncology as a Senior Manager in PV Sciences. At the forefront of pharmacovigilance innovation, ... on your experience in our rapidly evolving organization. Position Summary: The Senior Manager , PV Sciences role will support medical surveillance activities… more
