- Merck & Co. (Rahway, NJ)
- …of all Clinical Trials in scope for GCTO country operations.Adherence to GCP , local and global policies and procedures to conduct high-quality, inspection ready ... (QA) group and the Good Clinical Practice Quality and Compliance Council ( GCP QCC).Extent of Travel: up to 30%CORE Competency Expectations: Significant Management… more
- Merck & Co. (Rahway, NJ)
- …Research Organization (CRO) run studies. Adherence to Good Clinical Practice ( GCP ), local and global policies and procedures to conduct high-quality, inspection ... Assurance (QA) - group and the Good Clinical Practice Quality and Compliance Council ( GCP QCC). Represent GCTO and the Regions on strategic initiatives at all levels… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for operational and technical oversight of QA across GxP ( GCP /GVL/GCLP/GLP) systems.Lead the development of the global Data Integrity strategy and ... all applicable regulations related to computerized systems, including GxP ( GCP /GVL/GCLP/GLP).Collaborate with the Audits Compliance (RDPVMA) team to determine… more
- Merck & Co. (Rahway, NJ)
- …the candidate be responsible for the conduct of Good Clinical Practice ( GCP ) studies, and occasionally Good Laboratory Practice (GLP) studies.The Associate Principal ... each study.Ensure that the study is conducted according to legal requirements, GCP , and the applicable internal policies and procedures.Prepare the Final Study… more
- Eisai, Inc (NJ)
- …with Eisai TMF vision and transformation initiative and is compliant with ICH- GCP and regulatory requirements. This role also provides direction, leadership and ... eTMF system related activitiesEnsure eTMF system and associated process align with ICH- GCP , regulatory and Eisai SOPsOversight of eTMF vendor(s) and related TMF… more
- Merck & Co. (New York, NY)
- …field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilities. - Preferred Experience - ... Diversity and Inclusion (D&I), Employee Engagement, Good Clinical Practice ( GCP ), Hospital Medicine, Immuno-Oncology, Immunotherapy, Management Process, Medical Affairs,… more
- Eisai, Inc (Nutley, NJ)
- …the utmost compliance and quality consistent with Good Clinical Practice ( GCP ). This individual must effectively balance strategic vision with hands-on operational ... and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement strategic vision and hands-on… more
- Formation Bio (New York, NY)
- …ensuring performance benchmarks are met within cloud-based infrastructure (AWS, GCP , Azure). Rapidly prototype and iterate on machine learning solutions, ... data pipelines and deploying ML models in cloud environments (AWS, GCP , or Azure). Familiarity with model evaluation techniques, including cross-validation, A/B… more
- Beckman Coulter Diagnostics (Miami, FL)
- …the program meets the needs of cross-functional teams and complies with GCP , IRB policies and procedures, and applicable Standard Operating Procedures (SOP).Conduct ... in research, continuing review, closeout report).Thorough understanding of Good Clinical Practice ( GCP ).It would be a plus if you also possess previous experience… more
- Genmab (NJ)
- …high-quality clinical trial execution while ensuring adherence to Good Clinical Practice ( GCP ) guidelines and regulatory requirements. Our Sr CTA's are expected to ... become Subject Matter Experts (SMEs) for assigned processes and systems.The primary location for this role is Utrecht, The Netherlands. Candidates located in Denmark or the US are also welcome to apply.ResponsibilitieseTMF Management:Setup, maintain, oversee… more
- Twist BioScience (South San Francisco, CA)
- …software architecture certifications.Experience with cloud platforms (eg, AWS, Azure, GCP ) and DevOps practices.Direct experience participating in regulatory audits ... (eg, FDA inspections) specifically related to custom software and CSV.Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting dashboards.About Twist BioscienceTwist… more
- Merck & Co. (North Wales, PA)
- …operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilities.PreferredField-based medical ... experience-Research ExperienceDemonstrated record of scientific/medical publicationCurrent Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Early Clinical Development, Ethical Standards, Health Literacy, ICH GCP Guidelines, Informed Consent, Management Process, Manufacturing Compliance, Medical ... Writing, Motivation Management, Multi-Management, Project Management, Regulatory Compliance {+ 3 more}-Preferred Skills:Job Posting End Date:06/20/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please… more
- Taiho Oncology (FL)
- …disease states which are of interest to Taiho Oncology, study methodology, GCP , clinical information, and product data Demonstrate full knowledge of and ability ... to execute on approved medical platforms/strategies and Sr. Manager, Medical Field initiatives Serve as technical/scientific subject matter resource to Taiho commercial personnel, if requested Research Support: At the local level, identify opportunities for… more
- Genmab (NJ)
- …highly preferred.Solid understanding of clinical development and regulatory frameworks, including GCP and ICH guidelines.Proficiency with writing tools such as MS ... Word, EndNote, document management systemsAbility to interpret and summarize tabular and graphical data presentations.Experience with AI tools preferredAbout You - additional qualities you bring to the tableYou are capable of working on multiple tasks and… more
- Genmab (NJ)
- …data is appropriately documented for audits and inspections.Ensure adherence to GCP , GDMP, ICH, and global regulatory requirements.RequirementsBachelor's degree in a ... scientific, technical, or health-related field; advanced degree (MS, PhD) preferred.Minimum of 10 years of experience in clinical data management, clinical operations, or other related clinical research experience with at least 3-5 years in data oversight and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for projects/studies. This position has sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data ... Capture/related applications and industry standards, and advanced skills partnering with CROs and other third-party vendors. This position has excellent verbal/written skills, analytical, organizational, and people management skills and collaborates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to ensure all laboratory data management activities follow global ... SOPs, SOIs, and associated guidelines.- Remains current with and disseminates information about laboratory trends and advancements, emerging regulatory requirements, and technology innovations to optimize Daiichi Sankyo laboratory data processes.- Develops and… more
- Eisai, Inc (Nutley, NJ)
- …with other Health Authorities the CDE. Actively participates in Health Authority GCP inspections (eg, FDA, EMA, PMDA) including responding to observations and ... development of corrective actions. Keep abreast of changes in the regulatory environment and implement necessary adaptations. Provide expert opinion, advice and strategic direction on emerging policy & intelligence matters. Ensure continued engagement,… more
- Eisai, Inc (Nutley, NJ)
- …and in accordance with standard operating procedures (SOP), good clinical practice ( GCP ) and specific country regulations such as site and vendor selection, ... preparing clinical trial budgets. Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the… more
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