- UnitedHealth Group (Phoenix, AZ)
- …Ready to make a difference? Join us to start Caring. Connecting. Growing together. The Clinical Regulatory RN must be a subject matter expert (SME) for all four ... simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of… more
- BeOne Medicines (San Mateo, CA)
- …partnership and collaboration with cross functional leaders/stakeholders (eg Clinical Development, Data Management, Quality , Regulatory ) as it relates to ... PowerPoint and Project).** **Other Qualifications:** **Mid/large pharma experience (preferably clinical operations, process, quality , or compliance roles)**… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices (GCDMP). This position serves as a key liaison ... Directors, and Regulatory staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. + Focus on… more
- Prisma Health (Greenville, SC)
- …The Clinical Data Abstractor is responsible for collection, validation and clinical quality review of patient-level data for national clinical ... quality initiatives (ie, CMS core measures) or other clinical data registries (ie heart failure, cancer,...sponsoring/ regulatory entity (eg CMS Core Measures) or clinical -related databases or registries; develop efficient data … more
- GRAIL (Atlanta, GA)
- …Qualifications:** + **Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality , or program management ... 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… more
- CareSource (Dayton, OH)
- …of community partnerships within the CareSource network using reports generated from data /analytics, quality , population health and HEDIS to identify and ... Job Summary: The Women and Children Heath Regulatory Support Manager is responsible for planning, organizing,...within contracts/agreements. . Collaborate with internal stakeholders to use data to facilitate identification of gaps in clinical… more
- GRAIL (Menlo Park, CA)
- …and healthcare companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities ... closely with GRAIL study team members to ensure that clinical data captured is complete, consistent, and...system implementation and collaboration with study teams to ensure data quality . + Bachelor's degree required; advanced… more
- bioMerieux Inc. (Durham, NC)
- …and change), driving IVD (as well as RUO, Veterinary, and/or Clinical Industry) products through government/ regulatory approval processes. Capture and ... Position Summary A member of the RA team is responsible for developing regulatory strategy and assessing regulatory risks for products (for both registration… more
- Terumo Medical Corporation (Somerset, NJ)
- …and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes. Key responsibilities include planning ... Sr. Clinical Quality Specialist Date: Nov 19,...strategic input to clinical teams to ensure data integrity, regulatory compliance, and patient safety… more
- Lundbeck (Deerfield, IL)
- …active marketed products, by collaborating with cross functional teams during clinical development, regulatory submission and launch. + Supports Lundbeck ... Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location:...of all cross-functional labeling activities to maximize timebound high quality deliverables. + Responsible for the implementation and compliance… more
- Canfield Scientific, Inc (Parsippany, NJ)
- …with the ability to multi-task and prioritize, and is driven to deliver high- quality , evidence-based insights that shape clinical research outcomes. The ideal ... Carry out literature reviews to support study design, outcome development, and clinical , commercial or regulatory activities Prepare, write, and review study… more
- Terumo Neuro (Aliso Viejo, CA)
- … Safety, and Data Management. Ensure high standards of patient safety, data quality , and regulatory compliance while supporting the development and ... compliance. + Collaborate with Medical Affairs, Clinical Quality Assurance, Clinical Data Management...between Clinical Operations and departments such as Regulatory Affairs, Quality , R&D, PACE, R&D, and… more
- BeOne Medicines (Emeryville, CA)
- …Plan requirements and ability to translate them into operational metrics. + Experience with clinical data warehouses, and regulatory data reporting ... Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial diversity strategy through data -driven insights, performance… more
- CSL Behring (Waltham, MA)
- …due diligence and provide expert advice on bioanalytical and biomarker assays, data quality , regulatory expectations, clinic/submission readiness and ... difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA...and Biomarkers function. Ensure best practices in experimental design, data analysis, and compliance with regulatory requirements… more
- CSL Behring (Waltham, MA)
- …due diligence and provide expert advice on bioanalytical and biomarker assays, data quality , regulatory expectations, clinic/submission readiness and ... difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA...and Biomarkers function. Ensure best practices in experimental design, data analysis, and compliance with regulatory requirements… more
- Zoetis, Inc (Kalamazoo, MI)
- …and study sites. Maintain study files in accordance with SOPs and regulatory requirements. Implement and execute data management processes including paper ... Role Description Manager I (Parasitology) US Clinical Operations Global Clinical Research and...are not limited to: Prepare study protocols, amendments, deviations, data capture forms, electronic data capture systems,… more
- Parexel (Montpelier, VT)
- …with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of ... manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or… more
- Novartis Group Companies (Cambridge, MA)
- …GPCH is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements, ... GPCH is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements,… more
- Parexel (Columbia, SC)
- …with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of ... manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or… more
- Novartis Group Companies (East Hanover, NJ)
- …(GCT) is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements ... key documents (eg, Clinical Trial Protocols (CTPs), Investigator's Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of… more
