Clinical Research Consulting
Running a clinical trial is unlike anything else in your company. When the CRO isn't delivering, sites are falling behind, or regulators are asking hard questions, you need someone who has been there before. I work directly with biotech and pharma sponsors as an embedded senior consultant, so your program gets experienced leadership rather than a hand-off to junior staff.
About
I'm Shannon Jubb, a certified clinical research professional with two decades of experience across CRO, biotech, and pharmaceutical settings. I've managed global trials from startup through closeout as a CRO team manager, as a sponsor-side director, and as an independent consultant brought in when programs need to be rescued.
That dual perspective is what I bring to every engagement. I know what a CRO is supposed to be delivering and exactly where they tend to fall short. I know what Health Canada and the FDA look for in an inspection. And I know how to keep a trial moving when the situation is difficult.
Based in Victoria, British Columbia, working remotely with sponsors across North America and internationally.
Services
I work on a fractional basis — a few days a week, or a single defined project. Most engagements start small, with a focused assessment, and grow from there if it makes sense for your program.
A bounded piece of work with a fixed fee and a written deliverable, usually two to four weeks. A review of how your CRO is actually performing against contract. A feasibility check on enrollment assumptions before the protocol locks. A readiness assessment ahead of a filing or inspection. Useful on its own, and a low-risk way to find out whether we work well together.
Brought in when trials are off-track: CRO performance gaps, enrollment shortfalls, site relationship breakdowns, or data integrity concerns. I assess the situation quickly, rebuild what needs rebuilding, and get programs moving again. I've stabilized trials running 100 to 150 sites across multiple therapeutic areas, including mid-trial during COVID-19.
Embedded director-level support across the trial lifecycle: monitoring strategy, risk-based oversight, vendor contract and budget negotiation, site performance management, and real-time compliance reporting. Available part-time or fractional, scaled to what the program actually needs. You get a single accountable senior resource working with your team and your CRO, not a managed service that rotates staff.
SOP development, trial master file review, audit preparation, and compliance gap assessments. I've supported FDA and Health Canada site inspections directly and can bring your program's documentation to a defensible standard before regulators arrive rather than after.
Canada is harder than most sponsors expect — Health Canada requirements, hospital research ethics boards that each work differently, and a smaller patient population than the map suggests. If your program needs Canadian sites, whether for regulatory strategy, geographic breadth, or an investigator you want to work with, it is worth having someone who has done it before. I handle the full path: Health Canada submissions, REB coordination, site activation, and the documentation framework to support it.
Selected Experience
Every engagement is confidential. These are representative of the work I do.
Brought in as Director of Clinical Operations to recover a MASH cirrhosis program destabilized by the pandemic. Rebuilt vendor and site relationships, maintained protocol execution and data integrity across roughly 100 global sites, and delivered an interim data cut on schedule by establishing live compliance tracking. Directly supported both FDA and Health Canada site inspections.
Recovered enrollment across 150 sites for a rare disease trial that had fallen behind target, closing six months early and exceeding the enrollment goal by 10 percent. Built the site oversight model and KPI framework, introduced early-warning tools for enrollment bottlenecks, and mentored a clinical team of roughly ten through the recovery.
Led monitoring teams through a staffing recovery period following layoffs while enforcing performance standards and monitoring plan adherence. Closed the trial six months ahead of schedule by driving CRA and site accountability, implementing Veeva CTMS milestone tracking, and maintaining inspection-ready documentation throughout.
Therapeutic Experience
Phase I through IV experience across a broad range of therapeutic areas, in Canada, the United States, and internationally.
Contact
If you're a biotech or pharma sponsor dealing with a trial that's behind schedule, a CRO relationship that isn't working, or a program that needs senior clinical oversight, get in touch.
I work on a contract or fractional basis and can usually move quickly on an initial conversation. No intake process, no sales funnel. Just a direct discussion about whether I can help.