- IQVIA (Durham, NC)
- … regulatory support for complex projects and programs, part of our Clinical Trials Regulatory Management department. **RESPONSIBILITIES** + Acts as ... a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key… more
- J&J Family of Companies (Raleigh, NC)
- …of day-to- day aspects of investigational site activities on assigned clinical trials . The Clinical Research Associate should ensure compliance with ... Sr Clinical Research Associate - 2406209639W **Description**...trial /study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory… more
- United Therapeutics (Durham, NC)
- … trial design, study implementation, sponsor/site interactions, scientific and clinical methodology, protocol design, project management and regulatory ... approval for five medicines, we are always conducting new clinical trials , and we are working to...database generation and production of tables and listings; Ensure clinical trial material (CTM) is available for… more
- Astrix Technology (Raleigh, NC)
- …Clinical and Regulatory space. + Working knowledge of Clinical & Regulatory systems such as Clinical Trial Management System (CTMS), electronic ... for the sale and growth of Astrix Technology Group's Clinical and Regulatory Consulting services to a...Trial Master Files (eTMF), and Regulatory Information Management (RIM) + Must have a successful… more
- IQVIA (Durham, NC)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... IQVIA MedTech is seeking a Clinical Research Associate II with Medical...visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP)… more
- IQVIA (Durham, NC)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP)...required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- IQVIA (Durham, NC)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's...* Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. * ie, Good… more
- IQVIA (Durham, NC)
- IQVIA is seeking a Senior Clinical Research Associate with at least 2 years of monitoring experience in one of the following therapeutic areas: Central Nervous ... visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP)...required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- Medtronic (Raleigh, NC)
- …cardiology trials + Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials + Proficient in MS Office ... engineer or relevant hospital experience_ ) or + Associate degree with a minimum of 9 years of...including TMVR or LAAC or other adjacent therapies + Clinical Research experience including coordinating multi-center trials … more
- ThermoFisher Scientific (Morrisville, NC)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy… more
- Edwards Lifesciences (Raleigh, NC)
- …biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for clinical trials assigned to direct reports ... Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the...the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA… more
- Allucent (Cary, NC)
- …to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in ... need across the globe. We are looking for a Associate Director, Biostatistics (aDBios) to join our A-team (hybrid*/remote)....in the development and support of the analysis of clinical trial data + Prepare statistical analysis… more
- Grifols Shared Services North America, Inc (Raleigh, NC)
- … applications. This role focuses specifically on applications related to pharmacovigilance, regulatory , and clinical trials . Key responsibilities include ... within the application of the Scientific Innovation Office and Regulatory + Verify and/or perform functional, technical and/or impact...an equivalency could include 8 years of experience, an Associate 's degree with 6 years of experience, or a… more
- IQVIA (Durham, NC)
- …matter expert on related tools/applications. + Exhibits in-depth knowledge of clinical trial processes for data transformations, analysis, and governance. ... industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements. + Experience in clinical programming...source. + Experience and knowledge in all phases of clinical trials . IQVIA is a leading global… more
- ICON Clinical Research (Raleigh, NC)
- …and other regulations relevant to US Government Prime Awards in the context of clinical trials and healthcare.* Providing guidance and support on legal issues, ... to shape the future of clinical development. We are currently seeking a Legal Associate - Government Contracts to join our diverse and dynamic team. As a Legal … more
- IQVIA (Durham, NC)
- …scientific discipline or health care preferred. + At least 7 years prior clinical trial experience including experience in a management/leadership capacity or ... combination of education, training and experience. + Advanced knowledge of applicable clinical research regulatory requirements (ie, Good Clinical Practice… more
- J&J Family of Companies (Raleigh, NC)
- …and negotiate various types of domestic and international contracts such as: clinical trials ; research; consulting; research services; product; HCP; general ... Associate Corporate Counsel - 2406187341W **Description** Johnson &...company policies. + Identifying and analyzing pertinent legal, compliance, regulatory and business issues in order to help align… more
- United Therapeutics (Durham, NC)
- …we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials , and we are working to create an unlimited supply of ... and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Manager, Maintenance in support of the Regenerative Medicine Lab (RML) and… more
- Institute for Medical Research (Durham, NC)
- …provide training and guidance to others in the clinic. + Prior experience with clinical research, clinical trials , FDA regulations, VA regulations, and HIPAA ... and improvement of research software Critical Element 2 - Supervise Clinical Research Coordinators, Regulatory Coordinators, Project Scientists, and/or Business… more
- Sumitomo Pharma (Raleigh, NC)
- …and healthcare compliance guidance in all activities, including those related to clinical trials , scientific interactions with internal and external groups, and ... Medical Affairs function. This individual will lead program coordination with Clinical Development leadership to ensure alignment between Medical Affairs, Advocacy,… more