- Sun Pharmaceuticals, Inc (Princeton, NJ)
- **Title:** Senior Manager , Clinical Outsourcing Sun Pharma is the worlds fourth largest specialty generics company with presence in Specialty, Generics and ... a focus on dermatology, ophthalmology and onco-dermatology. **Description:** Sun is seeking a Senior Manager , Clinical Outsourcing within its Clinical … more
- Merck & Co. (Rahway, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- …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
- 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
- Parexel (Trenton, NJ)
- …Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, Recruitment Specialist, Clinical Data Scientist) + ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA)...Demonstrated knowledge in disease and technical areas pertaining to clinical studies , including knowledge of company direction,… 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 ...development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study… 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
- 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
- Actalent (Warren, NJ)
- As a Senior Manager Clinical Study Lead... study team responsible for the delivery of clinical studies and research collaborations. You will ... study systems. Responsibilities + Lead the cross-functional study team for clinical study ...Ensure accurate budget management and address scope changes for studies . + Escalate issues related to study … 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...of relevant high-quality clinical documents such as study protocols and clinical study … 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
- 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
- Mount Sinai Health System (New York, NY)
- …of the Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, ... the Clinical Research Coordinator II coordinates the clinical assessments of the study subjects; analyzes...genetic tests. + Independently obtains informed consent for other clinical studies . + Mentors Clinical … more
- Pfizer (New York, NY)
- …informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical ... for programs within the Late-Stage Oncology portfolio. **KEY RESPONSIBILITIES** + Clinical development expert for assigned studies maintaining current scientific… more
