San Diego, CA30+ days ago
Bachelors degree in a scientific or healthcare-related field Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry Minimum 2 years of experience leading a team of CRAs Recent experience working on respiratory, dermatology, and/or gastrointestinal clinical trials a plus Certification as a Clinical Research Associate (CCRA) or equivalent preferred Recent experience working on trials utilizing risk-based monitoring models Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet Experience with EDC systems, electronic trial master files (eTMFs), and other clinical trial databases and systems Strong understanding of clinical trial processes and study conduct Excellent organizational and time management skills Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight Experience working in a fast-paced and dynamic environment Successfully exhibit Apogee's C.O.R.E. The Clinical Monitoring Manager collaborates closely with the Apogee Executive Director, Clinical Operations, and the Clinical Study Lead, assists in the planning/management/execution of Apogee sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives.