- Cook Medical (West Lafayette, IN)
- …and procedures are correctly understood and applied; + Through close collaboration with Clinical Affairs global leadership, help ensure global alignment ... processes and sharing of best practices; + Work with Clinical Affairs global leadership to identify and...Develop and maintain a working knowledge of local and global regulatory requirements and standards (eg, FDA,… more
- Bristol Myers Squibb (Princeton, NJ)
- …for clinical programs, develop reports and publications on translational data generated to support asset development and contribute to regulatory submissions. ... and clinical development, developing biomarker strategies in alignment with clinical development objectives, leading efforts for data generation and… more
- Sumitomo Pharma (Juneau, AK)
- …and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output + Contributes to interpretation of clinical trial ... currently available therapies and competitive clinical landscape + Experience in conducting global clinical trials in both early- and late-stage clinical … more
- Medtronic (MN)
- …. This is a dynamic opportunity where you will also be involved in global clinical development activities and clinical strategy. **Prefer candidates who ... regulatory submissions, including regulatory responses. + Develop a deep understanding of clinical data : how to interpret and effectively communicate/present the… more
- Evident Scientific (Needham, MA)
- …leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards . The position serves as both a hands-on clinical ... submissions. ** Clinical Study Program Leadership** + Lead global clinical studies from concept to reporting;... clinical evidence synthesis. + Ensure alignment between clinical data , labeling, and regulatory claims. **Post-Market… more
- Houston Methodist (Houston, TX)
- …and safety as a direct reflection of practice and product variation with physician-level clinical data . Seeks information and serves to support clinical ... and overtime percentage, and other areas according to department specifications. + Uses clinical outcomes data as a primary driver of decision-making. Approaches… more
- IQVIA (Washington, DC)
- …is seeking a Clinical Database Design Manager to join our growing Clinical Data Management team. The ideal candidate will bring strong technical expertise ... integrations, and collaborating with cross-functional teams to deliver high-quality clinical data solutions.** **Key Responsibilities** **Design, build, and… more
- J&J Family of Companies (Irvine, CA)
- …indication expansions, postmarket surveillances, and registries + Analyze and interpret clinical data ; effectively communicate data using well-structured ... Adhere to external guidelines and Company policies governing the ethical development of clinical data publications while continuing to look at innovation in… more
- Lilly (Stamford, CT)
- …dissemination, and preparation of final study reports. + Analyze and contextualize clinical data to support decision-making and portfolio strategy. + Contribute ... laws, guidance (eg FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards , and Lilly... practice trends, access considerations, and relevant preclinical and clinical data . + Provide scientific consultation to… more
- Sanofi Group (Morristown, NJ)
- …development, which require a scientifically inquisitive, energetic and proactive person. + Ensure Clinical Trial standards are maintained at the site and in ... & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety… more