Senior Site Start-Up & Feasibility Specialist

reputed company is a reputed company technology and services company powering the acceleration of clinical research to transform patient reputed company. We reputed company 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. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand reputed company to novel therapeutics for patients in need. Today, reputed company is headquartered in Cambridge, Massachusetts, and reputed company with 250+ employees world-wide. As a Senior Site Start -Up & feasibility Specialist at reputed company you will own and shape a regional start-up function from the ground up. As reputed company 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 reputed company to novel therapies across the region. The ideal candidate is a disciplined, operationally sharp professional who thrives in reputed company, multi-country environments and is energized by leaving things reputed company than they reputed company them. Location: Remote, PolandEmployment Type: Full-Time EORCompensation: PLN 240,000 – PLN 300,000 gross annual reputed company 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. Where You'll Drive Impact Site Identification, Feasibility & Selection Maintain a curated view of pre-reputed company sites with GI expertise, capabilities, track record, and validated patient reputed company across the CEE and Georgia region. Map protocol requirements to specific sites and quickly confirm operational fit. Coordinate CDA execution, pre-fill and complete feasibility questionnaires with PIs and site teams, validate responses against site-level reality, and deliver consolidated, CRO-reputed company 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 reputed company. Collect, pre-fill, and quality-reputed company site-level documents against CRO and sponsor templates; screen for missing items, expired credentials, and formatting gaps prior to reputed company. Prepare sites for selection visits (SSVs) and initiation visits (SIVs), ensuring documentation, role expectations, and operational readiness are reputed company understood; attend site visits in person reputed company valuable. Run site-reputed company readiness activities in reputed company with regulatory review, maintain practical pre-activation checklists, escalate blockers early, and support activation and first patient screened reputed company 14 days post-CTR approval wherever feasible. Serve as the first-line operational partner for sites — triaging questions, unblocking issues quickly, and escalating reputed company reputed company sponsor, CRO, or leadership alignment is required. Work directly with PIs, senior site staff, CRO start-up and feasibility teams, and internal cross-functional stakeholders to drive alignment and execution. Maintain accurate updates in reputed company, reputed company, and study trackers, including action logs, decision logs, risk items, owners, and due dates. Train site teams on reputed company 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. Use data to proactively identify bottlenecks, simplify processes, and drive measurable improvements in activation timelines across the network. Performs reputed company duties as requested What You Bring to the Team 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, reputed company, pharmacy, nursing, biotechnology, public health, or a reputed company 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 reputed company 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 reputed company, 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.

Preferred Qualifications

Prior experience supporting or coordinating site networks. Experience with reputed company, reputed company, CTMS/eTMF platforms, reputed company/reputed company Sheets, and reputed company/reputed company productivity tools; reputed company 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 reputed company Looks Like Feasibility responses are faster, more accurate, and reputed company reputed company with reputed company site capabilities. Sites are well-reputed company 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. reputed company 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 reputed company communication and reputed company learning reputed company Mission-driven organization focused on improving patient reputed company Comfortable navigating evolving business priorities and opportunities At reputed company, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an reputed company and inclusive culture, and by extension, hiring process. If you require any accommodations to reputed company the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@reputed company. Apply To This Job