Rose Maloney, MA

Clinical Operations Leadership That Prevents Drift Before It Occurs

I stabilize studies, align cross-functional teams, and deliver predictable execution across global clinical programs from Phase I–IV.

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Operational Pillars

Operational Excellence

Predictable execution across complex studies.

Risk Anticipation

Drift identified before delays occur.

Monitoring Stability

Consistent oversight and CRA performance.

1. Operational Excellence

I create stable, predictable clinical operations environments that protect timelines and reduce execution risk across global programs.

  • Study startup calibration
  • Cross-functional workflow alignment
  • Milestone clarity from protocol to DB lock

2. Risk Anticipation & Prevention

Drift is detected early using operational signals before it becomes delay, rework, or audit exposure.

  • Protocol deviation trend analysis
  • Site performance monitoring
  • Proactive escalation coaching

3. Monitoring Stability

Consistent monitoring execution ensures data integrity and inspection readiness.

  • CRA coaching and upskilling
  • Visit report consistency
  • Query cycle-time compression

Targeted Microtraining

Short, role-specific reinforcement deployed only when operational risk appears. Designed to prevent drift — not teach theory.

Monitoring Consistency

CRA / CTM · 12 min

Protocol Deviation Prevention

Clinical Ops · 10 min

Vendor Escalation Discipline

Ops / Sponsors · 15 min

Submission Readiness Signals

Data / Medical Writing · 14 min

Why Teams Rely on My Leadership

Real-World Impact

NIH Pediatric Psychiatry
Asubio COPD Program
Schering-Plough Asthma

Request a Stability Assessment

A rapid review designed to reveal drift risks and operational gaps across your clinical program.

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