- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/ GCP Guidelines Review protocols to ... of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical...provided to Study Lead on trial metrics, data, and quality .Establish strong partnership with Functional and Regional Operational managers… more
- Merck & Co. (Rahway, NJ)
- …and oversight of local operational clinical trial activities-in compliance with ICH/ GCP and country regulations, company policies and procedures and-with quality ... compliance-to initial and ongoing trainings.Train and oversee the CORE competencies, ICH- GCP knowledge, Clinical Research environment etc.Assure adherence to GCP … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... relevant services/tasks in support of the design, planning & quality * delivery of clinical trials (including required staffing, training...years' experience in the design, planning and conduct of GCP clinical trials; with at least 6 of those… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Merck & Co. (Rahway, NJ)
- …and project management for assigned protocols in a country in compliance with ICH/ GCP and country regulations, our Company policies and procedures, quality ... for performance for assigned protocols in a country in compliance with ICH/ GCP and country regulations, our Company policies and procedures, quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... accordance with all relevant regulations and policies; (Good Clinical Practice ( GCP ), ICH guidelines, federal regulations (Sunshine/Open Payments Act), and within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific… more
- Merck & Co. (Rahway, NJ)
- …trial.Performs clinical study site management/monitoring activities in compliance with ICH- GCP ,-Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring ... and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and-escalates per defined CRA Escalation Pathway… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/ GCP and other regulatory ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....clinical research staff Advanced knowledge of Good Clinical Practice ( GCP ), ICH Guidelines, federal and local regulations, and clinical… more
- Taiho Oncology (New York, NY)
- …and Taiho's product(s) and compounds to ensure awareness and understanding. Provides high- quality scientific information to HCPs. Serves as a conduit for accurate ... disease states which are of interest to Taiho Oncology, study methodology, GCP , clinical information, and product data. Demonstrates full knowledge of and ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical ... data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, exploratory, etc.).… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical ... data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, etc.)… more
- Taiho Oncology (TX)
- …product(s) and compounds to ensure awareness and understanding. Provides high quality scientific information to healthcare professionals (HCPs) Serve as a conduit ... disease states which are of interest to Taiho Oncology, study methodology, GCP , clinical information, and product data Demonstrate full knowledge of and ability… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the ... quality and process validation requirements for existing products. Participate...or related science fieldDemonstrated knowledge and application of FDA cGMP/ GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11… more
- Eisai, Inc (Nutley, NJ)
- …is expected to be a team player, and an advocate for quality , compliance, professionalism, and core corporate values at Eisai. Responsibilities Responsible to ... project outcomes.Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.Strong communication and organizational… more
- Eisai, Inc (NJ)
- …business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to internal ... procurement experience, minimum 7 years pharmaceutical/clinical outsourcing.In-depth understanding of GCP /GLP guidelines, audit processes and agency regulatory requirements.Excellent verbal,… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …with Clinical Operations, Clinical Development, Biostatistics & Statistical Programming, Quality , Finance, IT, and Medical Affairs) through frequent interactions and ... database structures, and data exchangeIn depth understanding of regulatory, industry ( GCP ), and technology standards and requirements [ICH E6 and Regulatory… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Senior Manager, Global Development Quality Management ( GCP ) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... other functional areas. + Responsible for the management of GCP -compliant activities from a quality perspective in conjunction with the business and the GDQM… more
- GE HealthCare (IN)
- …and adaptation of quality assurance processes + Overall, the role of a GCP Quality Assurance Oversight Team Leader is critical for maintaining the integrity ... **Job Description Summary** The Global Compliance Quality Assurance R&D / GCP Leader is a crucial role within clinical research, particularly in the… more
- GE HealthCare (Boston, MA)
- … quality management system (QMS) improvements. + Overall, the role of a GCP Quality Assurance Auditor is multifaceted, requiring strong attention to detail, ... **Job Description Summary** The Good Clinical Practice ( GCP ) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are conducted… more
