- 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
- 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
- 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. (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
- 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
- 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
- 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
- Merck (Rahway, NJ)
- …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 (Madison, 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, ... 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
- Mount Sinai Health System (New York, NY)
- …teams, regulatory bodies, and institutional leadership to ensure the success of each study in the portfolio. Project Manager II develops and oversees the ... **Job Description** The **Project Manager II** will oversee the entire portfolio of...reflect current regulations, organizational policies, and best practices in clinical research. + Incorporate input from senior … more
- IQVIA (Parsippany, NJ)
- …is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and ... with the core project team and/or sub-team. + Accountable for assigned portion of clinical studies as per the contract while optimizing speed, quality and cost… 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
- Sanofi Group (Morristown, NJ)
- …Team. He/She will assume responsibility for methodological and statistical aspects of pre- clinical and/or non- clinical studies , with general direction from ... **Job Title:** Sr . Non- Clinical Biostatistician **Location:** Swiftwater, PA...Manager , CROs, etc.) + Under supervision of the senior manager of the TED team or… more
- System One (Plainsboro, NJ)
- …is required Job Summary The Senior Scientist, Health Economic Resources ( Sr Manager , RWE Analytics) will support the design, execution, and communication ... Job Title: Sr Manager , RWE Analytics Location: Plainsboro,...of experience working in the pharmaceutical industry analyzing RWE studies + Must have experience analyzing claims, EHR, registry… 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
