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

Work Schedule

Environmental Conditions

Job Description

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.

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.
  

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 between countries with concrete examples from previous studies.
• Knowledge of countries where additional national local institutional or committee approvals may be required outside the EU-CTR process and experience managing those requirements.
• A structured approach to identifying assessing escalating mitigating and monitoring start-up risks and issues.
• Proven ability to manage competing priorities across multiple countries balancing regulatory requirements site dependencies resources timelines and stakeholder expectations.
• Ability to lead influence liaise with and coordinate cross-functional and geographically dispersed project teams.
• Strong cross-cultural awareness and the ability to adapt communication and leadership approaches across different countries and stakeholders.
• Strong organisational project management and multitasking capabilities with excellent attention to detail.
• Ability to identify risks relating to contractual and operational deliverables and develop appropriate solutions.
• Comprehensive understanding of clinical research and clinical development including applicable guidelines directives study phases therapeutic areas and medical terminology.
  

• Bachelors degree or equivalent relevant academic/vocational qualification.
• Typically 5 years of relevant clinical research experience or an equivalent combination of education training and directly related experience.
• Demonstrated experience in clinical trial study start-up/site activation.
• Demonstrated regional EU start-up leadership with direct operational responsibility across multiple EU countries is essential.
  

• Work may be performed in an office laboratory and/or clinical environment.
• Role may involve exposure to biological fluids and infectious organisms with appropriate personal protective equipment required where applicable.
• Regular use of electrical office equipment and computer software developed both internally and externally.
• Occasional domestic and international travel of up to approximately 20% which may include travel outside normal business hours or at weekends.
• Ability to work effectively in a fast-paced environment manage changing priorities communicate with diverse stakeholder groups and perform under pressure.
  

When you join Thermo Fisher Scientific you become part of a global team united by a shared commitment to scientific excellence and helping our customers make the world healthier cleaner and safer.

Youll work in a collaborative environment where your expertise in European clinical trial start-up can directly contribute to the successful delivery of clinical studies and ultimately tomorrows scientific breakthroughs.