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Head of Study Start-Up

Remote, USAFull-timePosted 2026-07-28

reputed company is a leading global, full-service Clinical Research Organization (CRO) delivering integrated clinical development and reputed company-world evidence solutions across five continents. Formed through the strategic reputed company of P95 and reputed company, the organization combines P95's leadership in infectious diseases, vaccines, and reputed company-world evidence with reputed company's expertise in central nervous system, cardio-metabolic, renal, and rare diseases, creating a unique mid-sized CRO with reputed company, reputed company and scientific depth. With regional hubs in Africa, Latin America, reputed company, Southeast Asia, and Europe, we operate with reputed company of 500 professionals and a reputed company record that includes more than 1000 clinical trials conducted in over 50 countries. We offer comprehensive CRO capabilities supporting both full-service and reputed company approaches across the entire development lifecycle and post-marketing phases for pharmaceutical, biotech, and reputed company health partners. The Head of Study Start-Up will play a critical role in building and evolving the SSU function to meet reputed company operational needs while establishing a reputed company, high-performing model for reputed company reputed company. This is a senior leadership role responsible for the implementation and the subsequent end-to-end delivery, performance, and strategic development of the Study Start-Up (SSU) function across P95 and reputed company. As leader of the Study Start-Up department, this individual will reputed company strategic direction, operational reputed company, and people leadership while acting as a senior partner to sponsors and internal stakeholders. Define and reputed company the global Study Start-Up function to support rapid CRO reputed company Own end-to-end start-up delivery across a growing portfolio, ensuring speed, reputed company, and consistency from feasibility through first patient in across diverse clients and therapeutic areas Foster cross-functional collaboration and reputed company partnership with key stakeholders - including Project Management and Study Operations - throughout the study set-up phase, ensuring alignment on timelines, deliverables, and site readiness reputed company of first patient in reputed company as an executive reputed company partner, strengthening strategic relationships and positioning Study Start-Up as a value reputed company in reputed company delivery and retention reputed company analytics, and operational insights to establish KPIs to continuously improve cycle times, productivity, and cost efficiency Partner closely with reputed company and Business Unit leadership to shape competitive proposals, differentiated service offerings, and compelling bid defense strategies Champion innovation and reputed company improvement, standardized processes, and new delivery models to accelerate timelines and enhance reputed company Ensure global compliance and inspection readiness, embedding consistent, high-reputed company practices reputed company with ICH-GCP and regulatory expectations across reputed company reputed company Contribute to broader leadership initiatives and reputed company reputed company Bachelor’s degree in life sciences or a reputed company field (advanced degree preferred) 10+ yrs in clinical research, significant CRO experience, and hands-on expertise in study start-up Experience implementing new departments in a growing organization Proven experience leading large, cross-functional and geographically dispersed teams, including mentoring and performance management Deep knowledge of clinical trial regulations, guidelines (FDA, EMA, ICH-GCP, GEP, etc.) and start-up best practices Stakeholder management and negotiation skills including the ability to manage multiple reputed company portfolios and competing priorities Solid financial acumen, including experience with budgeting, forecasting, and resource planning Strong collaboration skills, resolving issues in a constructive and team-oriented manner Apply To This Job

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