- 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
- 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
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Manager , Clinical Research Finance Operations (Office of Clinical Research) ... D, Research, Administration Job Description Summary Responsible for the overall clinical research financial management and other financial matters of the… more
- CSL Behring (King Of Prussia, PA)
- …and within the agreed timeframe and budget. + Collaborate with Senior Managers, Clinical Finance to build and maintain robust study costing models for ... to the Associate Director, Business Operations Management, as the ** Manager , Clinical Financial Modeling** , you will...with Clinical Operations and POE to ensure study assumptions for all studies are up-to-date… 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 (Philadelphia, PA)
- …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
- ICON Clinical Research (Blue Bell, PA)
- Clinical Drug Supply Manager ICON plc...IP expiry. Ancillary Supplies + Develop plans for supplying clinical study sites with ancillary supplies, either ... reviews IVRS user manuals; Designs, reviews and approves IP-related study tools (for clinical study ...applies to internally sourced studies and/or CRO/Partnered studies . Collaborates and interacts with clinical trial… more
- Pfizer (Collegeville, PA)
- …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
- University of Pennsylvania (Philadelphia, PA)
- …Efficient time management and the ability to multitask to complete activities for multiple clinical studies at a given time are essential. This position requires ... Development & Efficacy (PDE) Manager Job Profile Title Technical Operations Manager - Clinical Cell and Vaccine Production Facility Job Description Summary… 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 (Philadelphia, PA)
- …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
- IQVIA (Abington, PA)
- … Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance ... on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.; * May attend site visits as… more
- Pfizer (Collegeville, PA)
- …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
- 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
- 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
- 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
