- Catalyst Clinical Research LLC (Raleigh, NC)
- …pancreatic or advanced solid tumor? We have a role for you! Job Duties: As a Senior Clinical Research Associate, you will monitor clinical trial programs ... experience. + Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all applicable regulations and… more
- ICON Clinical Research (Winston Salem, NC)
- …Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and ... and you'll be helping shape an industry. **The Role** **Title** : _Senior Clinical Research Coordinator_ **_Location_** _: Winston-Salem, NC_ . Adhering to the… more
- J&J Family of Companies (Raleigh, NC)
- Senior Scientific Integrator, Regulatory CMC Dossier - 2406190085W **Description** Janssen Research & Development, LLC, a division of Johnson & Johnson's ... Family of Companies, is recruiting for a Senior Scientist, Regulatory CMC Dossier - Biotherapeutics based in Spring House, PA. Remote work options may be… more
- ThermoFisher Scientific (Greenville, NC)
- … trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, ... depend on - now and in the future. The Senior Research Scientist (SRS), serves as the...clinical studies, including the leading of the overall research strategy development for proposals, the design and implementation… more
- IQVIA (Durham, NC)
- …of Project management practices and terminology. Req * Requires good knowledge of applicable clinical research regulatory requirements ie, Good Clinical ... Job Overview Senior Clinical Leads are an integral...clinical trial conduct, and skill in applying applicable clinical research regulatory requirements ie… more
- United Therapeutics (Durham, NC)
- … clinical trial material (CTM) is available for sites and/or Contract Research Organizations (CRO); Lead final clinical study report writing to summarize ... duties as required **For this role you will need** Minimum Requirements + For Senior ( Clinical ) Product Development Scientist level: + Bachelor's degree with at… more
- United Therapeutics (Durham, NC)
- …biopharmaceutical research & development or CRO + Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and ... II level: + 8+ years of experience in biopharmaceutical research & development or CRO + For Senior...and department processes + Experience with training and mentoring clinical research staff + Experience with … more
- ThermoFisher Scientific (Morrisville, NC)
- …for cancer. **How will you make an impact?** The **Sr. Director, Procurement - Clinical Research Group (CRG)** is the global leader responsible for developing ... agencies. + Requires strategic business partnering with Medical Affairs, Regulatory , Clinical Operations, Project Management, Patient Advisory Services and… more
- IQVIA (Durham, NC)
- **Job Level:** Senior Clinical Data Manager within DSSS **Location:** Home-based in the US or Canada **Why DSSS?** Data Sciences Staffing Solutions, DSSS or DS3, ... IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in… more
- Merck (Raleigh, NC)
- …management is preferred. **Experience:** + Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with ... Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those… more
- ThermoFisher Scientific (Greenville, NC)
- … trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, ... - now and in the future. Our Project Delivery colleagues within our PPD(R) clinical research services direct, coordinate and manage the technical and operational… more
- Merck (Raleigh, NC)
- …for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer: ... **Job Description** **Position Description:** ** Senior Medical Writer** The Senior Medical...+ Demonstrates independence in preparing clinical regulatory documents (eg, protocols, clinical study reports,… more
- Reynolds American (Winston Salem, NC)
- …data management activities in clinical studies and competent level of understanding clinical research processes and clinical data management lifecycle. + ... Ability to drive cross-functional collaborative efforts with multiple collaborators, internal clinical research partners and outsourced vendors. + Capacity to… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …about evolving regulatory requirements with regard to use of observational research in the life sciences sector, ensuring that conduct of RWE practices comply ... Overview:** The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and… more
- J&J Family of Companies (Raleigh, NC)
- …customers. * Provide statistical reports for data quality/performance metrics. * Assist Clinical Research with literature reviews and other activities. * May ... Senior Biostatistician - Biosense Webster, Inc. - 2406176946W...& RESPONSIBILITIES** **:** * Interact with Biostatistics, Data Management, Regulatory , and Clinical staff to define and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …statistical software) * Works with internal teams (eg, marketing, managed markets, clinical development) to support outomes research , quality of life, and ... and Outcomes Research (HEOR) in support of existing and new clinical applications in coordination with Global and US: Commercial, Medical Affairs, Clinical… more
- IQVIA (Durham, NC)
- …GCP/ICH and applicable regulatory guidelines. * Strong knowledge of clinical research financial parameters and project financial tracking and accounting ... Work with other functional management to develop implementation plans. Supervise Clinical Research Specialist (CRSs), Associate Directors and/or Managers.… more
- IQVIA (Durham, NC)
- …IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in ... a specific CDM task (eg Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where… more
- J&J Family of Companies (Raleigh, NC)
- …of core GCO business processes and practices (ie, SOPs and Systems governing clinical research activities) is required. + Ability to translate data into ... Holland-Leiden, Asia Pacific-Japan-Shinagawa-Tokyo, Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux **Organization** Janssen Research & Development, LLC (6084) **Job Function** Clinical… more
- IQVIA (Durham, NC)
- …IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in ... a specific CDM task (eg, Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where… more