- ThermoFisher Scientific (Greenville, NC)
- …Development Compliance and Clinical Quality Assurance. + Ensure high-quality deliverables for global studies or programs by guiding study teams on adherence to ... procedural documentation through detailed documentation review and active engagement with study team functional representatives. + Plan, monitor, and report on… more
- IQVIA (Durham, NC)
- …delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor's requirements. ... maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and… more
- ThermoFisher Scientific (Wilmington, NC)
- …knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services. ... + Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining… more
- IQVIA (Durham, NC)
- …The Principal Biostatistician is responsible for providing statistical support for drug development programs in early phases of development, focusing on healthy ... normal studies with PK and PD endpoints. **Additional Benefits:** +...to establish project timelines. + Provide statistical input to study synopses and protocols. + Write the statistical sections… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …will be involved in developing and executing proof-of-concept and mechanism-of-action studies , contributing to the understanding of drug mechanisms and ... department that specializes in developing and performing _in vitro_ assays to support drug discovery and bioanalyses of samples from _in vivo_ preclinical studies… more
- GRAIL (Durham, NC)
- …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 one ... seeking a compliance expert to support compliant conduct of Grail's clinical studies and to support Grail's partnerships with pharmaceutical companies for companion… more
- United Therapeutics (Research Triangle Park, NC)
- …review clinical protocols, data analysis plans, interpretation of results, clinical study reports, and supporting work for sections of regulatory submissions, such ... etc. + Prepare, present, and defend complex aspects of protocol design and/or study data at investigator and internal meetings + Prepare and review draft abstracts… more
- Sumitomo Pharma (Raleigh, NC)
- …the medical and scientific aspects of clinical trials, including protocol design, study endpoints, and data analysis. + Provide medical expertise to cross-functional ... programs, ensuring that the design, implementation, and conduct of the clinical studies provide unambiguous data and information that allows for clear decision… more
- IQVIA (Durham, NC)
- …Phase I-IV clinical studies . + Consult with Clinical Pharmacology staff on study design, analyses, clinical development plans. + Plan and execute a wide range of ... and CRO sectors. + Cohesive team environment fostering a collaborative approach to study work. + Variety of therapeutic areas, indications and, study phases.… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …amendment modification, and expedited report submissions, for: * Therapeutic clinical research studies involving a drug or device, and/or * Oncology clinical ... tracking and recording pending regulatory and compliance actions through completion on study team trackers and in clinical trial management system * Providing… more