Project Manager, Clinical Research (Remote)

Job description

Location MV Aliso Viejo, California, USA: Department Name: 652-Clinical Admin-Pre Market Operations Qualifications: 1. Bachelor’s degree in Life Sciences or related field 2. Minimum of six (6) years of direct clinical research experience (preferably in the medical device industry), including a minimum of four (4) years of demonstrated experience in clinical research project management (preferably in the medical device industry in support of IDE studies) 3. Minimum of one (1) year of leadership or supervisory responsibility 4. Knowledge of clinical study management, terminology, and related GCP and regulatory requirements 5. Familiarity with the logistics of clinical design and logistical elements such as study documentation development, site selection, budget development, IRB submission preparation, training, database/CRF development, contracts, informed consent, randomization, monitoring, statistical plans, and the tracking of study metrics 6. Strong verbal and written communication skills 7. Proficiency computer skills including MS Word, Excel, Access, PowerPoint, Outlook, Teams, etc. 8. Domestic and International travel required (~30%) Desired Qualifications: 1. Experience in de...