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Posted 2 hours agoSenior Site Start-Up & Feasibility Specialist
PolandOn-site
Responsibilities
- 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
- Coordinate CDA execution, pre-fill and complete feasibility questionnaires with PIs and site teams, validate responses against site-level reality, and deliver consolidated, CRO-ready feasibility input.
- 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 — keeping sites, CROs, sponsors, and internal teams aligned.
- Prepare sites for selection visits (SSVs) and initiation visits (SIVs), ensuring documentation, role expectations, and operational readiness are clearly understood; attend site visits in person when valuable.
- Run site-side readiness activities in parallel with regulatory review, maintain practical pre-activation checklists, escalate blockers early, and support activation and first patient screened within 14 days post-CTR approval wherever feasible.
- Maintain accurate updates in Salesforce, Asana, and study trackers, including action logs, decision logs, risk items, owners, and due dates.
- Train site teams on Iterative Health services, tools, checklists, and workflows.
- Convert recurring start-up issues into reusable templates, trackers, and lightweight playbooks across the European network.
- Monitor cycle times, feasibility turnaround, SIV-to-activation timelines, document query rates, site responsiveness, and screen/enroll trends.
Requirements
- By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
- 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.
- 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. •
- 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.
- 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. What Success Looks Like
Experience
- Performs related duties as requested What You Bring to the Team 5+ years of
Benefits
- Location : Remote, Poland Employment Type: Full-Time EOR Compensation: PLN 240,000 – PLN 300,000 gross annual base salary, plus annual bonus and benefits.
- Final compensation will be determined based on experience, skills, and internal equity.
- Benefits: Private medical coverage, life insurance, retirement benefits, paid time off, etc.
Contact
- experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Additional details
- Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.
- We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
- Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.
- 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.
- As Iterative Health scales its ex-US site network across Central/Eastern Europe and Georgia, this role sits at the center of that growth — building the systems, playbooks, and site relationships that will define how we activate studies across more than 20 sites and counting.
- Reporting to the Director of Clinical Research Operations for CEE, you won't just be executing a process; you'll be creating a repeatable, scalable model that accelerates patient access to novel therapies across the region.
- The ideal candidate is a disciplined, operationally sharp professional who thrives in complex, multi-country environments and is energized by leaving things better than they found them.
- Where You'll Drive Impact Site Identification, Feasibility & Selection
- requirements to specific sites and quickly confirm operational fit.
- Collect, pre-fill, and quality-check site-level documents against CRO and sponsor templates; screen for missing items, expired credentials, and formatting gaps prior to handoff.