- Takeda Pharmaceuticals (Raleigh, NC)
- …true to the best of my knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely and high ... of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides... data cleaning plan components, including edit checks ( data validation plan), listing review checks, … more
- United Therapeutics (Research Triangle Park, NC)
- …SAS Certified Professional: Clinical Trials Programming Using SAS 9.4 and + SCDM Certified Clinical Data Manager or Certified Clinical Data ... diseases, and other orphan diseases. **How you'll contribute** The Clinical Data Management Programmer is responsible for...team with design, validation , and implementation of clinical databases for designated studies + Assist data… more
- Fresenius Medical Center (Garner, NC)
- …the delivery of maximum quality care to all patients. + Must complete Clinical Manager training modules and ongoing developmental programs within the specified ... requirements. Ensure provision of quality patient care while maintaining cost-effective clinical operations in accordance with all legal, compliance, and regulatory… more
- Baylor Scott & White Health (Raleigh, NC)
- …the Health Catalyst Ignite migration and facilitates the transition of elements of the Clinical Analytics Platform to the Cloud Data Platform (CDP) powered by ... **JOB SUMMARY** The Sr. Project Manager is responsible for ensuring the success of...and ensure timely delivery of technical milestones. Support post-migration validation and testing processes to confirm data … more
- Amgen (Holly Springs, NC)
- … Integrity Assessments for Lab systems + Capable of defending Amgen's Lab systems validation and data integrity philosophy in an Audit situation + Any other ... Management System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Manager , QC Virology oversees the QC Virology team, ensuring GMP-compliant laboratory operations in accordance with regulatory guidelines. ... Virus (MMV) testing. As a technical subject matter expert, the Manager provides support for troubleshooting complex investigations and optimizing laboratory systems… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Labeling & Promotional Manager Date: Jan 23, 2025 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, ... revision, and maintenance of product labelling including the Company Core Data Sheet (CCDS), Target Product Labelling (TPL), United States Package Insert… more
- Amgen (Holly Springs, NC)
- …Management System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility ... for Data Integrity testing and business administration of Laboratory Computer...to act as a subject matter expert on instrument validation regulations and procedures. + Support evaluation of capabilities… more
- IQVIA (Durham, NC)
- …anticipate risks to minimize need for study level escalations. + Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under ... Data Management: Assist in reviewing or advising data management staff on database design, validation ...coworkers, managers and clients. + Working knowledge of relevant Data Standards (such as Clinical Data… more
- Amgen (Holly Springs, NC)
- …world. In this vital role you will the Engineer reports to the Senior Manager of the Process Engineering group. The position is responsible for providing daily ... of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable. + Own investigations of abnormal conditions… more
- Institute for Medical Research (Durham, NC)
- …to standard operating procedures (SOPs) as they apply to documentation and validation of clinical research statistics; provide recommendations for improvement of ... projects and perform advanced-level statistical analysis and programming for clinical research studies conducted by the Principal Investigator, Dr. Stephen… more
- Cayuse Holdings (Raleigh, NC)
- …that design complies with HHSC standards. This task also involves setting up validation and auditing processes to maintain data integrity post-migration. (10%) + ... Risk Module to a new SaaS solution. This includes comprehensive planning, data assessment, cleansing, and mapping to ensure compatibility with the new system.… more
- IQVIA (Durham, NC)
- …for laboratory staff and supporting the team in the absence of the line manager . + Performing routine data analysis to ensure analytical procedures are ... technical procedures and experimental execution in support of sample analysis and validation . You will also conduct root cause analysis, troubleshooting, and support… more
- IQVIA (Durham, NC)
- …are meticulously followed under the guidance of a dedicated lab services manager , researcher, or scientist. **What you'll be doing:** + Executing ELISAs, RIAs, ... and handling sample accessioning according to SOP using LIMS system. + Analyzing data , uploading results to LIMS system, and preparing stock buffers. + Prepare… more
- Medtronic (Raleigh, NC)
- …imaging/navigation equipment. + Lead and participate in product technical repair and clinical use training with domestic, international and 3rd party staff members + ... Provide testing and validation support to the manufacturer's organization, as applicable. +...School Diploma or equivalent required + 4 years technician, clinical field service or clinical customer support… more
- Cardinal Health (Raleigh, NC)
- …+ Completes Physician interactions (verbal calls outbound, follow up calls, clinical prescribing questions, diagnosis validation , outbound fax resolution, etc.) ... position_ for at least a year _Informed their current supervisor/ manager prior to applying_ _No written disciplinary action in...and laboratory products, and a provider of performance and data solutions for healthcare facilities. With 50 years of… more