Senior Clinical Trial Associate

We are building our Clinical team and need two Senior Clinical Trial Associates who are open to owning end-to-end processes. You will play a crucial role in the Clinical Development Operations (CDO) department to support the planning, execution, and management of clinical trials in accordance with regulatory requirements and industry best practices.

Requirements

• BA/BS degree or equivalent, relevant work experience
• Minimum of 5 years’ experience working on clinical studies in pharmaceutical, biotech, or CRO setting preferred
• Prior CTA experience required
• Excellent interpersonal and communication skills with ability to work collaboratively across functional teams
• Strong organizational and time management skills, and strong attention to detail
• Knowledge of global regulatory and compliance requirements for clinical research
• Experience with essential documentation for Trial Master Files required
• Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines
• Excellence with MS Office products Word, Excel, SharePoint, PowerPoint
• Experience working with clinical trial systems (CTMS, IRT, EDC) preferred