Principal Study Start-Up Associate
PharmaCROClinical ResearchRegulatory Affairs
Job description
Senior Study Start Up Associate - Hybrid - Romania ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Principal Study Start-Up Associate at ICON, you will be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals. What You Will Do: Your focus will be execution and oversight of clinical trial country submissions and approvals and negotiations of budgets and CTAs with sites. Key responsibilities include: Lead the negotiation and execution of Clinical Trial Agreements (CTAs), including site contracts and budget negotiations, ensuring timely study start-up. Manage and oversee clinical trial payments throughout the study lifecycle, including payment tracking, issue resolution, and close-out reconciliation. Prepare, review, and submit essential regulatory and site documentation to support approvals and successful site activation. Partner with local study teams and investigative sites to drive start-up activities and ensure milestones are achieved on schedule. Provide expert guidance on study start-up processes, requirements, and best practices, fostering strong collaboration and communication among stakeholders. Your Profile: You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience: Bachelor's degree in Life Sciences, Healthcare, or a related scientific discipline. Comfortable working in a hybrid environment, with the flexibility to attend the office 1–3 days per week. Strong knowledge of site budget development, contract negotiations, and local regulatory requirements, including submission and approval processes. Proven experience in clinical study start-up activities, with a solid understanding of regulatory frameworks and site activation requirements. Experience managing clinical trial site payments and payment reconciliation processes. Excellent organizational skills with a strong attention to detail and the ability to manage multiple priorities effectively. Strong verbal and written communication skills #LI-DS1 #LI-Hybrid Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here . Are you a current ICON Employee? Please click here to apply
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