VOTRE PROCHAIN CHAPITRE
Team Manager – Clinical Trial Start-Up Lead
À propos du poste
• Lead and oversee start-up activities across multiple EU countries
• Coordinate country teams and cross-functional stakeholders within a matrix environment
• Provide regional oversight of site activation activities against project timelines, quality expectations, and contractual commitments
• Navigate EU-CTR and country-specific regulatory and start-up requirements
• Manage country-specific documentation requirements and additional national or local committee approvals
• Coordinate information flow among project teams, clients, country teams, functional departments, and site-activation stakeholders
• Develop and implement start-up plans and guidelines using PPD/Thermo Fisher Scientific tools and processes
• Monitor and analyse project- and country-level start-up status, metrics, escalations, and recommendations for senior management
• Identify operational, regulatory, contractual, and timeline risks and develop mitigation and contingency plans
• Manage priorities, dependencies, timelines, and critical-path activities across multiple countries
• Coordinate feasibility, site contracts, country teams, and other assigned activities
• Collaborate on financial and contractual aspects related to site activation
• Establish controls to align project resources and expenses with agreed budgets and Global Project Management expectations
• Evaluate complex start-up issues, make business decisions, and implement agreed solutions
• Build effective customer and internal stakeholder relationships throughout project delivery
• Direct SSU/Study Start-Up leadership and oversight across multiple EU countries
• Practical knowledge of EU-CTR and its application to multi-country clinical trial start-up
• Understanding of country-specific EU-CTR implementation and documentation requirements
• Knowledge and experience managing additional national, local, institutional, or committee approvals outside the EU-CTR process
• Structured approach to identifying, assessing, escalating, mitigating, and monitoring start-up risks and issues
• Ability to manage competing priorities across multiple countries
• Ability to lead, influence, liaise with, and coordinate cross-functional and geographically dispersed project teams
• Strong cross-cultural awareness
• Strong organisational, project management, and multitasking capabilities with excellent attention to detail
• Ability to identify contractual and operational risks and develop appropriate solutions
• Comprehensive understanding of clinical research and clinical development, including applicable guidelines, directives, study phases, therapeutic areas, and medical terminology
• Bachelor’s degree or equivalent relevant academic/vocational qualification
• Typically 5+ years of relevant clinical research experience, or equivalent combination of education, training, and directly related experience
• Demonstrated clinical trial study start-up/site activation experience
• Demonstrated regional EU start-up leadership with direct operational responsibility across multiple EU countries
• Ability to work effectively in a fast-paced environment, manage changing priorities, communicate with diverse stakeholder groups, and perform under pressure
• Ability to travel domestically and internationally up to approximately 20%
• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Appropriate personal protective equipment where applicable
• Collaborative work environment
• Up to approximately 20% domestic and international travel