Iterative Health

Role Description As a Senior Site Start-Up & Feasibility Specialist at Iterative Health, you will own and shape a regional start-up function from the ground up. This role sits at the center of growth as Iterative Health scales its ex-US site network across Central/Eastern Europe and Georgia. - Build systems, playbooks, and site relationships to activate studies across more than 20 sites. - Create a repeatable, scalable model that accelerates patient access to novel therapies. - Work closely with the Director of Clinical Research Operations for CEE. - Thrive in complex, multi-country environments. Qualifications - 5+ years of experience in clinical operations, site start-up, feasibility, site management, or senior clinical research coordination, preferably in Phase 2–4 pharma-sponsored trials. - Bachelor's degree or higher in life sciences, healthcare, pharmacy, nursing, biotechnology, public health, or a related field; advanced degree and/or clinical research certification preferred. - Hands-on CRO and/or sponsor-facing experience in site identification, selection, feasibility, and study start-up activities. - IBD clinical trial experience. - Strong understanding of ICH-GCP, site operations, regulatory and start-up documentation, SSV/SIV preparation, and early recruitment readiness. - Experience coordinating multiple sites and countries, ideally across Central/Eastern Europe, Georgia, or similarly complex regional environments. - Proven ability to manage trackers, timelines, action logs, document QC, and stakeholder communication with disciplined execution. - Strong ability to identify operational risks early, escalate clearly, and drive issues to resolution. - Clear written and verbal communication skills in English; regional language skills are a plus. - Willingness to travel approximately 20% across Central/Eastern Europe and Georgia for site visits. Requirements - Prior experience supporting or coordinating site networks. - Experience with Salesforce, Asana, CTMS/eTMF platforms, Excel/Google Sheets, and Microsoft/Google productivity tools; EDC familiarity is a plus. - Experience supporting clinical trials in MASLD, obesity, and/or cardiology. - Experience creating SOPs, playbooks, site-facing templates, trackers, or training materials. - Experience working in fast-growing, remote-first, international teams. Benefits - Private medical coverage - Life insurance - Retirement benefits - Paid time off - Annual bonus What You'll Drive Impact - Maintain a curated view of pre-qualified sites with GI expertise, capabilities, track record, and validated patient access across the CEE and Georgia region. - Map protocol requirements to specific sites and confirm operational fit. - Coordinate CDA execution, pre-fill and complete feasibility questionnaires with PIs and site teams. - Drive feasibility quality and speed to improve turnaround times and accuracy across the network. - Orchestrate day-to-day execution across sites from CDA/feasibility through CTR readiness, SSV/SIV, activation, and early recruitment readiness. - Collect, pre-fill, and quality-check site-level documents against CRO and sponsor templates. - Prepare sites for selection visits (SSVs) and initiation visits (SIVs). - Run site-side readiness activities in parallel with regulatory review. - Serve as the first-line operational partner for sites. - Maintain accurate updates in Salesforce, Asana, and study trackers. - Train site teams on Iterative Health services, tools, checklists, and workflows. - Convert recurring start-up issues into reusable templates, trackers, and lightweight playbooks. - Monitor cycle times, feasibility turnaround, SIV-to-activation timelines, document query rates, site responsiveness, and screen/enroll trends. - Use data to proactively identify bottlenecks and drive measurable improvements in activation timelines. What Success Looks Like - Feasibility responses are faster, more accurate, and better aligned with real site capabilities. - Sites are well-prepared for SSVs, SIVs, activation, and early recruitment. - CROs and sponsors receive clean, complete, and timely site-level documentation. - Start-up blockers are identified early and escalated before they impact activation timelines. - Site activation and first patient screened timelines improve measurably across the CEE network. - Iterative Health has a repeatable, scalable start-up and feasibility model across Central/Eastern Europe and Georgia. How We Work - Collaborative and low-ego team environment - High ownership and accountability culture - Fast-paced and highly iterative growth environment - Open communication and continuous learning mindset - Mission-driven organization focused on improving patient outcomes - Comfortable navigating evolving business priorities and opportunities