Start-up Team Manager – EMEA Clinical Trial Start-Up Lead - FSP

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Start-up Team Manager – EU Clinical Trial Start-Up Join Thermo Fisher Scientific as a Start-up Team Manager, taking a leadership role in the delivery of complex clinical trial start-up activities across Europe. This position requires demonstrated regional EU study start-up leadership, with direct operational responsibility across multiple EU countries. The successful candidate will bring hands-on knowledge of EU Clinical Trials Regulation (EU-CTR) requirements, country-specific start-up pathways, and the practical differences that must be managed when activating studies across European markets.   Please note: Experience leading start-up activities within a single country, even when combined with broader exposure to EU studies, is not sufficient for this position. Candidates must be able to demonstrate direct oversight and accountability for start-up delivery across multiple EU countries.   What You’ll Do As Start-up Team Manager, you will provide operational leadership and oversight for site and country activation activities, working across functions and geographies to ensure studies progress according to agreed timelines, quality standards, regulatory requirements, and budgets.   Key responsibilities include: Lead and oversee start-up activities across multiple EU countries, coordinating country teams and cross-functional stakeholders within a matrix environment. Provide regional oversight of site activation activities, ensuring delivery against project timelines, quality expectations, and contractual commitments. Navigate EU-CTR requirements alongside country-specific regulatory and start-up requirements, recognising and proactively managing variations between European markets. Understand and manage country-specific documentation requirements, including variations or additional documentation associated with EU-CTR submissions. Identify and coordinate additional national or local committee approvals and requirements that sit outside the EU-CTR process, where applicable. Coordinate the flow of information between project teams, clients, country teams, functional departments, and other stakeholders involved in site activation. Develop and implement start-up plans and guidelines using established PPD/Thermo Fisher Scientific tools and processes. Monitor and analyse project and country-level start-up status, providing meaningful metrics, escalation, and recommendations to senior management. Proactively identify operational, regulatory, contractual, and timeline risks and develop effective mitigation and contingency plans. Manage competing priorities, dependencies, and timelines across multiple countries while maintaining visibility of critical-path activities. Coordinate feasibility, site contracts, country teams, and other activities within the assigned scope of work. Collaborate with project teams to manage financial and contractual aspects of studies relating to site activation. Establish appropriate controls to ensure project resources and expenses remain aligned with agreed budgets and Global Project Management expectations. Evaluate complex start-up issues, interpret available information, make sound business decisions, and ensure agreed solutions are implemented. Build effective relationships with customers and internal stakeholders throughout project delivery.   What We’re Looking For We are particularly interested in candidates who can demonstrate substantive, hands-on leadership of EU study start-up activities at a regional level. Successful candidates should be able to clearly demonstrate: Direct SSU/Study Start-Up leadership and oversight across multiple EU countries, including the specific countries for which they have held operational responsibility. Practical knowledge of EU-CTR and its application to multi-country clinical trial start-up. Understanding of how EU-CTR implementation and documentation requirements can vary