Clinical Operations Manager

Hybrid –Ewing Area , NJ (Travel Required)

Area clinical operations pro who thrives at the intersection of strategy, oversight, and hands-on leadership? My client—a fast-growing biopharma advancing meaningful global studies—is searching for a Clinical Operations Manager who can elevate trial execution, sharpen CRO performance, and mentor CRAs while keeping every study inspection-ready.

This is your chance to lead high-impact trials across in-house and outsourced models, shape monitoring strategy, and ensure quality that stands up to global regulatory scrutiny.

Why You Should Apply

• Lead complex trials across global regions with true operational authority
• Hybrid role with high visibility and direct influence on clinical success
• Work cross-functionally with Clinical Dev, DM, Stats, Safety & Regulatory
• A culture that values rigor, collaboration, and decisive leadership
• Competitive compensation + excellent benefits (details provided during interview)
  
  

What You’ll Be Doing

• Oversee all operational aspects of assigned trials—start-up through close-out
• Manage CRAs and IHCRAs; coach, review deliverables, ensure monitoring quality
• Drive CRO oversight: KPIs, governance, performance management
• Ensure TMF accuracy, inspection readiness, and documentation excellence
• Lead RBM strategy, SDV/SDR optimization, and centralized monitoring activities
• Support audits/inspections and act as escalation point for complex site issues
• Monitor enrollment, deviations, CAPAs, and timeline risks
  
  

About You

• 8+ years clinical research + 6+ years on-site CRA experience
• Strong oversight skills (in-house + CRO models)
• Expert in GCP, RBM, and inspection readiness
• Strong communicator, mentor, and cross-functional partner