Acts as the primary medical point of contact for trial-specific safety and medical questions, ensuring patient safety and well-being.
Provides medical input for regulatory responses, reviews safety reports and study documents, and manages trial risks related to medical monitoring.
Participates in trial meetings, feasibility assessments, and client interactions while training teams on therapeutic and protocol medical aspects.
PSI is a leading Contract Research Organization focusing on delivering quality and on-time clinical trial services across various therapeutic areas. The company has over 30 years of industry experience and offers a balance of stability and innovation to clients and employees.
Oversees all aspects of study site management to ensure patient safety and data quality, including site visits, monitoring reports, and risk management.
Manages site start-up procedures such as regulatory submissions and investigator contracts, and ensures investigational product handling compliance.
Performs data review and query resolution, communicates proactively with sites and project teams, and maintains site and trial master files.
Precision for Medicine is a clinical research organization (CRO) that integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences to accelerate the development of life-changing therapies, particularly in Oncology and Rare Disease. The company fosters a professional culture where employees' ideas are valued and nurtured, aiming to impact positive change.
Support the design, execution, and analysis of clinical studies, ensuring GCP and regulatory compliance while managing protocols and clinical documents.
Perform comprehensive data review to identify trends and safety signals, and collaborate on data query resolution and system consistency.
Contribute to clinical document development and data dissemination, including protocols, study reports, and abstracts for publication.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company advancing cell therapies for autoimmune diseases. The company is building the foundation for the next generation of cell therapy with a culture guided by core values like staying true to purpose and bold innovation, operating at a critical scaling stage.