Kategória: Munka, állás
Honlap:
Részletek...Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description OBJECTIVES/PURPOSE Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved. Support sites and study teams to achieve rapid site start up. ACCOUNTABILITIES Work directly with assigned sites on all site related essential document collection and review. Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes. Ensure standards are applied to the SSU processes across projects. Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc Promptly recognize and improve potential site activation delays and escalate to appropriate team members. Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned. Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team. Review and provide feedback to management on site performance metrics. Ensure accuracy and completeness of the eTMF for assigned sites during start up DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge) Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.) Understanding of Clinical Trial Agreements, budgeting and fair market value principals Knowledge or FDA and ICH-GCP guidelines for conducting clinical research Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change) Demonstrated ability to work across functions, regions and cultures The ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both id...
