Sponsor oversight.
Operational leadership.
Delivered flexibly.
I help biotech sponsors, CROs, and growing clinical organizations build solid operational foundations — without the overhead of a full internal team.
- Former CRO founder — built and led clinical operations teams from scratch (hiring, training, leading, overseeing and assessing CRAs)
- Certified GCP Auditor — an inspection-readiness lens on every decision, from vendor selection to team-building
- Engagement: fractional, operational, mission-based, or project-based — via FlowTrial or directly, starting small and scaling as needed
EU and US experience across international multi-site studies.
The same pressure points, every time.
- Limited resources for operational quality infrastructure
- Rapid growth, no scalable framework in place
- CRO/vendor relationships hard to manage or track
- Inspection risk from fragmented documentation
- First trial, no structure yet — vendors not selected or assessed
- Trial scaling (Phase IIa → IIb, or Phase II → III) — more vendors, sites, and regions than the original setup can track
- Need senior leadership, not a full-time hire
"I fill these gaps — fast, pragmatic, hands-on, independent and autonomous from day one."
Two contracting paths. Same senior expertise.
Toggle between the two to see how each is structured.
Engagement Modes
How each path can be structured, specifically:
Three ways I add structure.
Fractional & Operational Leadership
- Embedded fractional or interim clinical ops leadership
- CRO/vendor management: selection, performance, issue resolution
- Operational troubleshooting for struggling sites, vendors, or CROs
- Feasibility & study start-up support
- Vendor selection & assessment, structure from day one
Sponsor Oversight & Quality
Sponsor oversight, plainly: consistent, documented CRO/vendor oversight — issues tracked from detection to closure.
- Oversight visit execution (on-site)
- Remote oversight activities
- SOPs, templates, and logs for consistent, documented oversight
- CRO and vendor performance evaluation
- CRA performance assessment during oversight visits
- Issue tracking & closure — found, resolved, by whom, how long
- Inspection readiness — proactive or at-risk
- ICH E6(R3) / GCP implementation strategy
Team Building, Training & CRA Leadership
12 years founding and scaling a CRO/SMO — hiring, training, leading teams.
- Hiring, training, leading, overseeing and assessing CRAs and clinical ops staff
- Building teams and processes from scratch — sponsors, CROs, startups
- GCP training delivery for site networks and investigator teams
- Sponsor Oversight Monitor/Manager training course — live, certificate-awarded, AI Copilot included; open cohort or delivered in-house for your CRA team or internal resources
- Speaker — CRA Connect Live 2026, Barcelona (May 2026): "The CRA Mindset Shift: From Monitoring Details to Recognizing Patterns Across the Study"
Where this expertise has the most impact.
Nearly 20 years, ten therapeutic areas, three continents.
Co-founded and ran a CRO/SMO in Romania for over a decade, then pivoted independently to sponsor oversight and international operations since 2022.
| # | Therapeutic Area | Study Type | Phase | Patients (approx.) | Sites | Region | Sponsor | Role |
|---|---|---|---|---|---|---|---|---|
| 1 | Respiratory | Sore throat / acute respiratory infections | — | ~250 | 10 | Romania | Undisclosed | CRA |
| 2 | Infectious disease — vaccines | Adult vaccination | Phase II–IV | ~2,500 (2 studies) | 15 national | Romania | Big Pharma (GSK) | Associate Director / Co-Founder |
| 3 | Infectious disease — vaccines | Pediatric vaccination (newborns) | Phase II–IV | ~800 | ~10 national | Romania | Big Pharma (GSK) | Associate Director / Co-Founder |
| 4 | Respiratory | COPD & Asthma | Phase II–III | >2,000 (10+ studies) | — | Romania | Big Pharma (GSK) | Associate Director / Co-Founder |
| 5 | Respiratory — biologics | Asthma & COPD | Phase II–III | ~90 (2 studies) | ~12 national | Romania | Big Pharma (GSK) | Associate Director / Co-Founder |
| 6 | Immunology / Autoimmune | Lupus (SLE) — non-interventional | Phase IV | 2 | 20 | Romania | Big Pharma (GSK) | Associate Director / Co-Founder |
| 7 | Oncology | Network feasibility study | Feasibility | N/A | 12 | Romania | Big Pharma (GSK) | Freelance Consultant |
| 8 | Cardiovascular | Hypertension | Phase II–III | ~1,500 (2 studies) | — | United States | Startup (George Medicines, London UK) | Clinical Operations Director / Sponsor Oversight |
| 9 | Cardiovascular | PK study | Phase II–III | ~50 | 1 | Czech Republic | Startup (George Medicines, London UK) | Clinical Operations Director / Sponsor Oversight |
| 10 | Rare disease — ophthalmology | Thyroid Eye Disease (TED) | Phase II–III | 50–70/study (4 studies) | 15 | EMEA (UK, France, Spain), USA occasionally | Pharma (Beaufort CRO / Viridian, USA) | Sponsor Oversight & Clinical Quality Assessor |
| 11 | Hematology/Oncology — MDS | Anemia in MDS — dose-escalation study (molecule/protocol confidential) | Phase II | — | 1 of 43 | Spain | Pharma (Beaufort CRO / Takeda) | Sponsor Oversight & Clinical Quality Assessor |
Physician specialties engaged: General practitioners · Pediatricians · Pneumologists · Allergologists · Immunologists · Cardiologists · Endocrinologists · Ophthalmologists · Otorhinolaryngologists (ENT) · Oncologists · Hematologists Patient numbers and site counts are approximate. Molecule names and protocol numbers omitted for confidentiality.
Based in Barcelona. Working across Europe and North America.
Fractional operational leadership · CRO/vendor relationship management · Operational troubleshooting · Sponsor oversight (CRO/vendor evaluation, documentation, issue tracking) · Feasibility & study start-up · Team building & CRA leadership · Trainer · Speaker · Sponsor oversight training (certificate course) · GCP Auditor certified · Inspection readiness · ICH E6(R3) · SOP development