Associate Director, Clinical Operations (Site Operations)

Role

Associate Director, Clinical Operations, providing strategic leadership over site start-up and ongoing site management for late-phase, post-marketing, and real-world studies in biopharma.

Responsibilities

• oversee site documents, IRB submissions, budgets, safety notifications, study communications, and site closeout;
• develop and monitor operational metrics;
• implement best practices;
• support team development;
• ensure compliance and inspection readiness;
• lead process improvement initiatives.

Requirements

• 6+ years in clinical site start-up and operations;
• experience with Phase 4, post-marketing, or real-world studies preferred;
• strong leadership, communication, and data-driven decision skills;
• familiarity with clinical trial systems such as CTMS (Veeva preferred).

HighValue

HighValue: late-phase studies, Phase 4, post-marketing, real-world data, clinical site management, metrics-driven improvements, CTMS systems.

Work Setup

full-time in the U.S., no visa sponsorship; collaborative, cross-functional environment.