Boutique, senior-level support for site activation, regulatory operations, and CRO oversight, from an operator who has run cardiovascular device trials across the United States, Europe, and East Asia.
I work as a fractional partner: hands-on, senior-level operational support without the overhead or rigidity of a full CRO. Engagements are tailored to where you are in the study lifecycle and what your team actually needs.
End-to-end management of the operational steps required to activate clinical sites, from feasibility and site selection through regulatory binders, investigator onboarding, and first patient in. Includes coordination of core-lab and imaging vendors where a trial carries echo, CMR, or ECG endpoints.
Comprehensive support for ethics submissions and ongoing regulatory management, including initial submissions, amendments, continuing reviews, and multi-site coordination for both industry-sponsored and investigator-initiated studies.
Site contract and budget support through negotiation with institutional stakeholders, CROs, and sponsors, plus sponsor-side oversight of your CRO so a lean team stays in control of its own trial. Includes budget development, coverage analysis, and contract workflow management to reach workable agreements efficiently and protect sponsor interests.
My career has been built inside cardiovascular clinical research. Managing trials from feasibility through pivotal at a major US academic medical center, working across sites in the United States, Europe, and East Asia, and operating at the intersection of sponsors, sites, CROs, and core labs. Most of that work has been cardiac device trials, with substantial drug and some cell therapy experience as well.
My focus is operational execution. I stand up sites, manage IRB and regulatory submissions, negotiate budgets and contracts, and keep CROs and vendors accountable, so a small team can run a rigorous trial without building a large internal infrastructure.
That experience runs deep on the vendor side, including ECG and imaging core-lab programs across echocardiography and CMR, where I have coordinated multi-site data collection, site training, and quality management across multi-continental trials. It means I know how to manage the specialized vendors a cardiovascular trial depends on.
I bring an international perspective shaped by professional experience across four continents and personal ties to both the European and MENA research communities. When you work with Shifa Trials, you work with me directly.
I work best with focused teams that need senior operational expertise without a full-time hire or a large CRO engagement.
Academic spin-outs and small teams developing cardiac devices, preparing for or running feasibility and pivotal studies without dedicated operational staff. Drug and cell therapy programs welcome as well.
European and other international teams navigating the FDA pathway and US clinical trial infrastructure for the first time. I bridge regional research culture and US regulatory expectations, with direct networks across Europe and the MENA region.
Research teams and investigators who need structured operational support, from IRB management to contract execution, without the overhead of a full CRO engagement.
Companies activating multiple sites for the first time. I support the systems, processes, and coordination needed to scale without losing compliance or momentum.
A 30-minute conversation about your study, your team's current needs, and where things stand. No obligation.
I map out what's needed, what your team already has, and where hands-on support will have the most impact.
Project-based or short retainer, depending on your lifecycle phase. Most engagements run 2–6 months.
Hands-on, responsive, and direct. I work inside your team, not around it.
Tell me where you are in the study lifecycle and what's slowing you down. I'll follow up to schedule a brief introductory call to see if we're a good fit.
Request an Intro Call