Team Manager – Clinical Trial Start-Up Lead

This is a fully remote position, open to applicants in Spain, +3 more countries.

📋 Description

• Lead and manage start-up operations across various EU nations.

• Coordinate teams at the country level and engage with cross-functional stakeholders in a matrix setup.

• Oversee regional site activation activities to ensure alignment with project timelines, quality standards, and contractual obligations.

• Navigate the requirements of EU-CTR alongside country-specific regulatory and start-up guidelines.

• Handle documentation requirements specific to each country and secure any additional approvals from national or local committees.

• Facilitate the flow of information among project teams, clients, country teams, functional departments, and stakeholders involved in site activation.

• Create and execute start-up plans and guidelines utilizing PPD/Thermo Fisher Scientific tools and methodologies.

• Monitor and evaluate project and country-specific start-up status, metrics, escalations, and provide recommendations for senior leadership.

• Identify operational, regulatory, contractual, and timeline risks while devising mitigation and contingency strategies.

• Manage priorities, dependencies, timelines, and critical-path activities across several countries.

• Oversee feasibility studies, site contracts, country teams, and other assigned tasks.

• Collaborate on financial and contractual matters related to site activation.

• Establish controls to align project resources and expenditures with agreed budgets and Global Project Management standards.

• Assess complex start-up challenges, make informed business choices, and implement agreed-upon solutions.

• Cultivate strong relationships with customers and internal stakeholders throughout project execution.

⛳️ Requirements

• Direct leadership and oversight of SSU/Study Start-Up across multiple EU nations.

• Practical expertise in EU-CTR and its application in multi-country clinical trial start-ups.

• Understanding of country-specific implementation and documentation needs under EU-CTR.

• Knowledge and experience in managing additional national, local, institutional, or committee approvals beyond the EU-CTR framework.

• Methodical approach to identifying, assessing, escalating, mitigating, and monitoring start-up risks and challenges.

• Ability to juggle competing priorities across various countries.

• Proven capability to lead, influence, engage with, and coordinate cross-functional and geographically diverse project teams.

• Strong cross-cultural awareness.

• Excellent organizational, project management, and multitasking skills with a keen attention to detail.

• Ability to pinpoint contractual and operational risks and formulate suitable solutions.

• Thorough understanding of clinical research and clinical development, including relevant guidelines, directives, study phases, therapeutic domains, and medical terminology.

• Bachelor’s degree or equivalent relevant academic or vocational qualification.

• Typically, 5+ years of pertinent clinical research experience, or an equivalent combination of education, training, and directly related experience.

• Proven experience in clinical trial study start-up and site activation.

• Demonstrated leadership in regional EU start-up with direct operational oversight across multiple EU nations.

• Ability to operate effectively in a fast-paced environment, adapt to changing priorities, communicate with diverse stakeholder groups, and perform under pressure.

• Willingness to travel domestically and internationally up to approximately 20%.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Provision of appropriate personal protective equipment where necessary.

• Collaborative work environment.

• Up to approximately 20% domestic and international travel.