- IQVIA (Durham, NC)
- …accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on Harmonization (ICH) ... in applying, applicable clinical research regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on Harmonization (ICH)… more
- GRAIL (Durham, NC)
- …with cross-functional teams (eg, Regulatory, Quality Assurance, Lab Operations, Clinical Data Management, etc.), and senior leaders to establish inspection ... a key leadership role in shaping and strengthening Grail's Clinical Quality Management System (CQMS) and advancing...CFR Part 812 and Part 11]. + Experience managing GCP quality processes such as managing … more
- Bausch + Lomb (Raleigh, NC)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, ... GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...purposes. **POSITION REQUIREMENTS** **:** + Strong knowledge of Good Clinical Practices ( GCP ), clinical trials… more
- IQVIA (Durham, NC)
- …with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice ( GCP ), protocol), customer requirements (contract), ... **Job Overview** Provide oversight and leadership to Senior Global Trial managers (SGTMs) for project productivity,...all Clinical Leads (CLs) obtain Fundamental Good Clinical Practices ( GCP ) accreditation during a two… more
- ThermoFisher Scientific (Greenville, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Clinical Team Manager ( Senior )** PPD's (a part of Thermo Fisher ... Project Manager to ensure the necessary training, tracking and quality systems are in place for the clinical...of moderate to high complexity, in compliance with ICH GCP . In accordance to project specific requirements, may assume… more
- IQVIA (Durham, NC)
- …and manage clinical risks throughout the project lifecycle. + Ensuring clinical quality delivery by identifying quality standards, planning compliance ... measures, and managing clinical quality issues. + Managing clinical aspects of...management practices and terminology. + Good knowledge of applicable clinical research regulatory requirements ( GCP , ICH guidelines).… more
- Deloitte (Charlotte, NC)
- Senior Data Scientist, Specialist Senior - SFL Scientific Our Deloitte Strategy & Transactions team helps guide clients through their most critical moments and ... in building industry-specific, artificial intelligence (AI) technologies. We are hiring a Senior Data Scientist to collaborate directly with clients to design and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees ... **Data Integrity:** Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality ...industry environment + Strong knowledge of current global Good Clinical Practice ( GCP ) for designing, recording and… more
- Novant Health (Wilmington, NC)
- …RAPS or similar, required. Current CITI HSP (Human Subjects Protections) and CITI GCP (Good Clinical Practice), required. + Additional Skills (required): + ... engage senior leaders and stakeholders. + High proficiency in clinical research technologies, data analysis, budget management, and resource allocation in… more
- IQVIA (Durham, NC)
- …- Perform senior biostatistical review (SBR). - Produce or perform quality control review of sample size calculations for complex studies. **Requirements:** - MS ... In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice ( GCP ), and International Conference on Harmonization (ICH)… more