Associate Director Clinical Operations

Associate Director, Clinical Operations

The Associate Director, Clinical Operations will help forward this mission by proactively managing program-level operational aspects of global clinical trials, including managing CRAs, developing study operational plans, conducting onsite initiation and monitoring visits, and tracking key clinical quality indicators.

Responsibilities

• Focus on monitoring oversight (for both our client and CRO's sites)
• Thoroughly the details of each monitoring visit
• Work with CRAs on a day-to-day basis, conduct co-monitoring visits and review 100% of their reports (approximately 30% average travel)
• Work with program management and other functions while preparing for and executing the monitoring visits
• Manage in-house CRAs on key clinical programs.
• Develop high-quality study operational manuals and plans, including a Clinical Monitoring Plan and Protocol Deviation Handling Guid...