- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader ... Authority Engagement:** Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections... Integrity:** Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality… more
- Sumitomo Pharma (Austin, TX)
- … clinical research and global regulatory requirements + Experience managing safety data , expedited individual and aggregate periodic safety reporting, ... of clinical trials, including monitoring of clinical trial safety and laboratory data... Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on… more
- Houston Methodist (Baytown, TX)
- …quality functions that may include but are not limited to patient safety , clinical outcomes, risk management, infection control, performance improvement, quality ... a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/ regulatory required safety … more
- Sumitomo Pharma (Austin, TX)
- …and/or cross-functional inspection readiness and operational improvement activities. + Collaborate with Clinical Development to interpret safety data from ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job… more
- Baylor Scott & White Health (Grapevine, TX)
- …issues. The director develops key metrics for clinical quality and patient safety and directs data testing, trending, forecasting, and reporting to improve ... compliance with state and federal safety regulations. + Partners with clinical and corporate compliance to manage regulatory surveys, certifications, and… more
- Houston Methodist (Houston, TX)
- …**QUALITY/ SAFETY ESSENTIAL FUNCTIONS** + Supports department with data abstraction for regulatory /accreditation requirements and/or performance/process ... the reporting of data as applicable to scope of department. Ensures regulatory compliance by timely submissions of the required report forms to the CIBMTR… more
- Houston Methodist (Sugar Land, TX)
- …staff. **SERVICE ESSENTIAL FUNCTIONS** + Analyzes submitted information including clinical assessments, treatment plan, regulatory guidelines, medical necessity, ... related to reimbursement or denial mitigation. + Provides communication to providers about regulatory guidelines for clinical content in a readable format and… more
- Datavant (Austin, TX)
- …team of product managers and product designers and collaborate deeply with data science, clinical experts, engineering, and commercial teams to accelerate ... a crucial role in expanding a platform that empowers clinicians with data -driven disease predictions, improving clinical decision-making, patient outcomes, and… more
- Houston Methodist (Houston, TX)
- …documentation, organization and safety of research participants, gathering patient data for clinical research activities via methods specified in the ... study protocol and performing general administrative and regulatory duties supporting the study. This position will also support the expanded access program for… more
- UTMB Health (Galveston, TX)
- …with clinical and anatomic pathology laboratories on patient safety initiatives, regulatory and accreditation compliance, risk management, laboratory ... and improvement activities related to clinical guidelines, healthcare quality/ safety initiatives, accreditation and regulatory requirements, in collaboration… more