- Merck (Rahway, NJ)
- …in collaboration with Data Management/Programming. + Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of ... This includes the ability to: + Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH) + Ability to manage multiple competing priorities… more
- IQVIA (Carlsbad, CA)
- …applying, applicable clinical research regulatory requirements. * ie, Good Clinical Practice ( GCP ) and International Conference on Harmonization (ICH) ... IQVIA Biotech is hiring for our Early Clinical Development team. Ideal candidates will have Phase...manage ongoing project expectations and issues. * Evaluate the quality and integrity of study site practices related to… more
- Bristol Myers Squibb (Princeton, NJ)
- …The Senior Manager, Data, Analytics and AI Product Engineer- Clinical Data Management, Global Drug Development Information Technology (GDDIT), Data & Analytics ... BMS. **Key Responsibilities:** + Accountable for delivering strategy, planning, and high- quality technology solutions for Clinical Data Management portfolio. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. **_Objective / Purpose:_** The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution ... outsourcing models, including financial and commercial constructs + Sound understanding of GCP , ICH guidelines, and clinical trial regulations + Strong strategic… more
- GRAIL (Menlo Park, CA)
- …technology, and healthcare companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities ... and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome… 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
- BeOne Medicines (Emeryville, CA)
- …and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH- GCP guidelines, local regulations, and ... applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to...through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery… more
- AbbVie (North Chicago, IL)
- …vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical ... of AbbVie's Quality Manual principles, standard business procedures, and GCP -related regulations Key Stakeholders Senior Leaders within Clinical … more
- Catalent Pharma Solutions (Kansas City, MO)
- **Supplier Quality Assurance Senior Specialist** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization ... Solutions in Kansas City, MO is hiring a Supplier Quality Assurance Senior Specialist. The Supplier ...tasks that support the Global Comparator and Depot Supplier Quality Management and Clinical Packaging Network site… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, ... the following:** * Collaborate with our Manufacturing, Research and Clinical Studies QA teams to ensure seamless integration of...Studies QA teams to ensure seamless integration of IT quality assurance practices. * Lead all aspects of the… more
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