- Seattle Children's (Seattle, WA)
- …and leadership to the Seattle Children's Research Institute in quality analysis and regulatory support for clinical research. Leads overall business planning and ... set QA policies and standards that support the achievement of high-quality clinical research for our patients and families. Responsible for establishing and… more
- GRAIL (Menlo Park, CA)
- …**Required Qualifications:** + MS or PhD with 10+ years of experience in regulatory , development, clinical affairs, quality, or program management within the ... Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical , statistical, or regulatory settings-especially in oncology, immunology,… more
- BeOne Medicines (San Mateo, CA)
- …Study Teams (CST) and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC). + Work with Clinical ... + Coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing,… more
- Stanford Health Care (Palo Alto, CA)
- …regime to promote informed decision making. + Ensures compliance with legal, regulatory and clinical policies and procedures. **Education Qualifications** + ... is waiting to be discovered. Day - 10 Hour (United States of America) Clinical Nurse Specialist for inpatient surgical acuity adaptable units. **This is a Stanford… more
- BeOne Medicines (San Mateo, CA)
- …for Phase I-III clinical trials, incorporating functional inputs across global clinical operations, start-up, regulatory , safety, medical & clinical ... Senior Manager Clinical Costing System and Pricing will support the...our enterprise resource need estimating tool for Phase I-III clinical trials (Rainbow). This role will be responsible for… more
- Integra LifeSciences (Trenton, NJ)
- …complex clinical deliverables in accordance with internal GSOPs, and regulatory guidelines including clinical sections for regulatory documentation ... environment across multiple functional teams. Has solid understanding of the different clinical and regulatory development functional areas and roles. +… more
- Parexel (Carson City, NV)
- …and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience ... part of driving success for our clients and advancing clinical research projects. As a part of the Global...Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group… more
- CSL Behring (King Of Prussia, PA)
- … clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the ... statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions + Influence and contribute to clinical … more
- Parexel (Washington, DC)
- …and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing ... analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need… more
- Cordis (Miami Lakes, FL)
- …with internal stakeholders, to include Clinical Affairs, Professional & Clinical Education, Regulatory Affairs, Quality Systems, Marketing, Sales as well ... IRB and publishers. The candidate should have a strong background in the clinical evaluation process, with a track record of successfully managing the remediation of… more
- CSL Behring (King Of Prussia, PA)
- …program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and ... methodologies applied to study design and data analysis for clinical trials and regulatory submissions. 2 Provide statistical support in data collection, data… more
- GRAIL (Durham, NC)
- …post-analytical-strong process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks. This position is **onsite ... high-throughput laboratory automation and advanced instrumentation. + Deep understanding of clinical laboratory regulatory standards, including CLIA, CAP, NYS,… more
- Parexel (Tallahassee, FL)
- …Parexel** At Parexel, we are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical ... on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a… more
- Stony Brook University (Stony Brook, NY)
- …of Health, College of American Pathologists (CAP) and other applicable accreditation and regulatory authorities. TH Clinical Lab Tech IV, III, II. * Maintains ... Clinical Lab Technologist II -Blood Gas Technician **Position...Communicate effectively with Main Laboratory, Point of Care Dept., regulatory agencies and vendor technicians * Assist in teaching… more
- BeOne Medicines (Emeryville, CA)
- …SOPs** **Effective partnership and collaboration with cross functional leaders/stakeholders (eg Clinical Development, Data Management, Quality, Regulatory ) as it ... **General Description:** **The Head of Global Clinical Process Management is responsible for designing, implementing, and optimizing processes across multiple… more
- GRAIL (Menlo Park, CA)
- …data lifecycle, from sample ingestion through analysis, ensuring every step meets rigorous regulatory and clinical standards. We are seeking a Staff Software ... data pipeline development, with demonstrated success delivering data solutions for clinical or regulatory use cases. Hands-on experience with relational… more
- BeOne Medicines (Emeryville, CA)
- …Clinical Operations learning and development initiatives, ensuring alignment with the clinical trial lifecycle, GCP, and global regulatory requirements. + ... **General Description:** The Associate Director Change Management Global Clinical Operations Learning and Development is responsible for leading the organizational… more
- CSL Behring (King Of Prussia, PA)
- …standardization across systems, studies, and functions? + Collaborate with teams (eg, Safety, Regulatory , Clinical , IT) to embed PV data standards into systems ... and quality in safety data management across the R&D organization, supporting regulatory readiness and scientific integrity. **The Role** + Maintain PV data… more
- BeOne Medicines (Emeryville, CA)
- …colleagues in clinical development, program management, biometrics, clinical operations, safety/pharmacovigilance, regulatory , molecular diagnostics, and ... research, ideally across Phases I-III + Strong understanding of clinical trial design, GCP and regulatory environment...understanding of clinical trial design, GCP and regulatory environment for submissions (IND, CTA, NDA, BLA) +… more
- US Physical Therapy (Brunswick, GA)
- …equipment + Document patient progress accurately and timely, maintaining compliance with clinical and regulatory standards + Communicate clearly with patients, ... caregivers, and the clinical team + Support overall clinic operations and collaborate...other staff as needed + Adapt quickly to different clinical settings and patient populations throughout the travel coverage… more
