8+ years leading Phase II-IV clinical programs. MD-level scientific fluency. Zero critical findings across 25+ studies. Senior research leadership embedded in your team within one week.
You know the pattern. Sites activated late. Enrollment targets missed quarter after quarter. Documentation gaps surfacing days before an audit. Meanwhile, every month of delay burns through your runway and puts your next sponsor call, board update, or investor meeting at risk.
You don't need another body. You need someone who can own the outcome.
Plug in your program's numbers. See the cost of inaction and the impact of embedded clinical research leadership.
Estimates based on industry benchmarks and Dr. Engineer's documented outcomes across 25+ studies. Actual results vary by trial complexity, therapeutic area, and organizational readiness. Phase multipliers reflect typical cost differentials across trial phases.
Not a list of tasks. Not a job description. These are the measurable results your clinical program gains from embedded research leadership.
Enrollment 40% behind target at month 6. Lead site had zero patients enrolled in 4 months. Sponsor considering protocol amendment to salvage timelines.
Conducted risk-based site assessments, identified root causes, developed targeted performance improvement plans, and launched investigator re-training across 8 sites.
Site start-up averaging 120 days. Contract negotiations stalling. Regulatory submissions incomplete across multiple geographies.
Redesigned site qualification criteria, streamlined contract workflows, and implemented pre-submission checklists with proactive IRB/IEC coordination.
Fractional research leadership isn't for everyone. Here's how to know if this model is the right fit for your team and program.
You're a small or mid-size biotech that needs senior clinical expertise without a full-time hire
Your trial has enrollment shortfalls or site activation delays and you need someone who can own the turnaround
You need audit readiness and regulatory compliance leadership before an upcoming inspection
Your junior CRAs are capable but lack senior mentorship and strategic direction
You're a CRO seeking experienced oversight for a complex or high-stakes study
You need a full-time, on-site CRA for routine monitoring visits
Your program only needs data entry or basic administrative CRA support
You're looking to fill a temporary seat with a contract CRA
Your trial is fully staffed with experienced senior leadership already in place
Engagement models designed for 6 to 18 month fractional partnerships. Plug into your team at the leadership level without the overhead.
Developed during her tenure leading clinical operations at Parexel International, Dr. Engineer's PRISM Framework is a comprehensive methodology for managing complex trials. It addresses the root causes of operational failure by integrating five disciplines into a single, cohesive system. Because it's documented, teachable, and transferable, it protects your program from the institutional knowledge loss that typically follows personnel transitions mid-trial.
Trial designs that prioritize participant experience, decentralized elements, and continuous patient feedback loops
Proactive risk assessment focused on critical data points, with 90%+ site-level challenges resolved before impacting timelines
Cross-functional collaboration and technology platform integration that eliminates silos and redundant workflows
Peer mentorship, simulation-based learning, and real-time feedback that reduce onboarding time by 30%
Clear KPIs, continuous monitoring, and data analytics that drive measurable operational improvement
The complete methodology behind 30% compliance improvements, 35% faster site start-ups, and zero critical findings across 25+ studies. See exactly how Dr. Engineer runs clinical programs.
Traditional contract CRAs execute tasks. A fractional Clinical Research Leader owns outcomes. The difference is strategic thinking, MD-level clinical judgment, and leadership that elevates your entire operation.
No 6-month recruiting cycle. No agency markup. A streamlined path to senior clinical research leadership on your team.
30 minutes to understand your trial, your team gaps, and where senior leadership would have the highest impact. No commitment.
A clear engagement plan: scope of work, deliverables, timeline, and investment. Tailored to your program's complexity and stage.
Fully integrated into your team within the first week. On sponsor calls, in your CTMS, driving site performance from day one.
I went to medical school because I wanted to help people get better. Somewhere along the way, I realized the biggest impact I could have wasn't in a single exam room. It was in making sure the trials that lead to new treatments actually work the way they're supposed to.
After 8+ years leading Phase II through IV programs, I've learned something that still surprises people: the biggest risk to a trial is rarely the science. It's the operations. The enrollment plan nobody revisits. The TMF nobody audits until the night before an inspection. The junior CRA who's talented but has never had a mentor show them what great looks like.
Those are the problems I solve. I built the PRISM Framework because I kept seeing the same patterns derail good programs. Patient-centered design, risk-based oversight, systems that actually talk to each other, real training, and metrics that mean something. That's how I've driven 30% improvements in protocol compliance and built teams that keep performing long after I'm gone.
If any of that sounds like what your program needs right now, let's talk.
Aureus University School of Medicine
University of British Columbia
Parexel International
ImmunoHorizons, AHA
Adopted Across Parexel Teams
3 Trials, 450+ Patients, <90 Days
Research-backed analysis of the operational challenges that derail clinical programs, and what the data says about fixing them.
The average Phase III trial costs $42,000 per site per day in operational overhead. When timelines slip, the financial damage compounds fast, and most teams dramatically underestimate how much.
80% of clinical trials fail to meet their enrollment deadlines. The root causes are predictable, preventable, and almost always operational, not scientific.
The average VP Clinical Operations hire takes 6+ months to fill. For a biotech burning $500K-$2M per month, that's not a hiring timeline. It's a runway problem.
I embed directly into your team on a part-time or fractional basis, typically 15 to 30 hours per week depending on the program's needs. I attend your sponsor calls, access your CTMS and TMF systems, and operate as a member of your team. The difference from a full-time hire is the flexibility: you get senior-level leadership scaled to your current stage without long-term overhead.
Most engagements run 6 to 18 months, aligned with the lifecycle of the trial or the specific challenge we're solving. I scope every engagement with clear deliverables and milestones so both sides know what success looks like. Onboarding is fast. I'm typically embedded and contributing within the first week.
Absolutely. Many of my engagements involve working alongside a CRO, providing the sponsor-side oversight and strategic direction that ensures the CRO is delivering to plan. I've managed CRO performance across multi-site programs and can serve as the senior point of accountability between your internal team and external partners.
Engagements are scoped with a clear monthly retainer based on the expected time commitment and deliverables. No middleman markups, no hourly surprise invoices. We agree on the scope, the rate, and the timeline upfront. If the scope changes, we revisit the terms together.
My focus is on the strategic and operational leadership layer: program oversight, risk-based monitoring strategy, team development, and performance management. If your program also needs on-site monitoring, I can help build or manage the team that handles site visits while I provide the centralized oversight and direction.
Walk me through your clinical program, where the gaps are, and what's keeping you up at night. If there's a fit, I'll outline a clear scope of work and engagement model. If there isn't, I'll tell you that too.