- Novo Nordisk Inc. (Plainsboro, NJ)
- …matter experts (SMEs) to develop and deliver specialized training content for clinical trials , regulatory submissions, and medical communications Ensure training ... The Position We are seeking a detail-oriented and passionate Training Manager to join our Clinical , Medical, Regulatory (CMR) group at Novo Nordisk. This role is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and company SOPs regarding adverse event reporting from post-marketing sources and clinical trials complaint handling Ensures local/affiliate SDEA templates meet ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Parexel (Trenton, NJ)
- …The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed ... Tools (RACT) and Quality Plans in partnership with the Clinical Trial Team (CTT). + Collectively and...digital data management (ie use of novel technology within clinical trials ). + Build and enable effective… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Parexel (Trenton, NJ)
- …or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience required + Master's of Science or Master's of Business ... **Job Summary:** The Digital Medicine and Translational Imaging Study Manager will play a critical role in ensuring the...degree with a minimum 6 years of relevant operational clinical trial experience required + A scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials , clinical safety, pharmacovigilance Must have ... around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP...US and European regulatory requirements for the conduct of clinical trials . Ability to provide interpretation and… more
- Parexel (Trenton, NJ)
- …an analytical, detailed oriented, problem solver with proven experience leading and managing clinical trials with a passion for working in early phase. **What ... out to schedule an introductory conversation.** **Job Title:** Project Manager (Early Phase) **Location: must be located in one...limited to):** + Lead a variety of early phase clinical trials located at one of Parexel… more
- Unknown (Somerset, NJ)
- …company's pipeline. The Global CMO will be responsible for leading the execution of clinical trials , providing strategic direction for clinical teams, and ... in both US and Chinese markets. Deep knowledge of clinical trial design, regulatory requirements, and GxP...regulatory experience, and the ability to manage complex, multinational clinical trials . A strategic mindset, strong operational… more
- Unknown (Warren, NJ)
- …processes, and a deep knowledge of the operational aspects of all phases of clinical trial conduct. The role requires a leader with strong management, ... Executive Medical Director, Clinical Development, Obesity About the Company Rapid-growing pharmaceutical...programs that meet decision milestones and regulatory requirements. Hiring Manager Title Internal Medicine CVRM VP Therapeutic Area Lead… more
- Parexel (Trenton, NJ)
- …studies, as applicable and/or appropriate for the MD + Providing risk assessment of clinical trials for local sponsorship as needed with the support of the ... and propose /execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction...-Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical… more
- Unknown (Warren, NJ)
- …fostering a high-performing R&D organization, ensuring the successful delivery of NDA filings, clinical trials , and product launches, and serving as a champion ... desirable. The ideal candidate will have a strong understanding of regulatory requirements, clinical trial design, and CMC, and demonstrate the ability to build… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …and may author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments + Assists with and may ... therapeutic areas as well as a proven track in clinical trial process improvements. We need an...leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical… more
- Taiho Oncology (Princeton, NJ)
- …design, conduct, monitoring and review of study data, analysis and reporting of clinical trials . Performance Objectives: + Collaborates with other key team ... Biomarkers and Medical Writing etc.), to deliver high quality clinical trial results. + Use scientific expertise...+ Keeps Sr. Medical Director current on status of clinical trials and provides ongoing risk assessments… more
- Bristol Myers Squibb (Princeton, NJ)
- …& completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database lock. **Position Summary** The Senior ... plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists with and may author/review ... The Senior Manager , Hematology, Clinical Scientist leads in...process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical trial process improvements. Considerable organizational awareness,… more
- J&J Family of Companies (Titusville, NJ)
- …Practices. + Ensure that manipulated drug products and finished products produced for clinical trials are released in accordance with the cGMP and the ... Description:** Johnson & Johnson is currently recruiting for a ** Manager External Clinical Supply Quality!** This position...and in a timely manner to prevent patient or trial impact. + Remain current with EMEA/FDA and local… more
- Bristol Myers Squibb (Princeton, NJ)
- …15+ years of demonstrable experience in pharmaceutical industry with proven expertise in clinical trial execution, data acquisition, and analysis reporting on a ... meaningful, consider joining our diverse team! As the Product Manager for the Clinical Data Ecosystem within...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
- Stryker (Trenton, NJ)
- …guidelines, GCP, and regulatory requirements. This includes establishing and maintaining clinical trial databases, ensuring all data-related operations comply ... **Principal Clinical Data Manager (Remote)** We are...+ Develop complex status reports, specifications for analysis of clinical trial data for interim and final… more
- Bausch + Lomb (Trenton, NJ)
- …**Key Activities:** + Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical ... form (ICF) development, site selection and communication with senior clinical trial sites regarding all logistics including...+ Provides clinical oversight and management for clinical trials to facilitate compliance with FDA… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. ... maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial...performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and… more
