Study Start Up Manager

Join our Clinical Operations team in a client-dedicated (FSP) role, supporting a leading global pharmaceutical company. This is a home-based position in the UK, where you will play a key role in the planning, coordination, and oversight of study start-up activities across the UK and selected European countries.

This is an exciting opportunity for an experienced clinical research professional with a strong background in Study Start-Up, site activation, country start-up, and clinical trial submissions. Working closely with cross-functional teams and stakeholders, you will help drive efficient study delivery by supporting country and site start-up strategies, managing timelines, and ensuring operational excellence throughout the start-up phase.
 

The ideal candidate will bring practical experience of performing country-level clinical trial start-up activities and regulatory/ethics submissions across the UK and Europe. They will be confident using relevant application systems and platforms, including UK and EU submission systems where applicable, and will have strong knowledge and/or experience of the requirements involved in setting up and activating clinical trial sites.
 

This country and site start-up expertise will be complemented by strong organisational, stakeholder management, and project delivery skills. Candidates should be comfortable coordinating study start-up activities, managing timelines, identifying risks, and driving deliverables to completion. Any previous project management experience  can be developed through ownership and coordination of start-up activities across multiple countries or sites and supporting larger and more complex clinical trial programmes.
 

• Support and Oversee Study Start-Up activities across the UK and selected EU countries from country feasibility through site activation.
• Drive site activation timelines and proactively identify, manage, and escalate risks to study milestones.
• Support the implementation of country-level and study-specific start-up strategies aligned with sponsor objectives.
• Oversee start-up deliverables and ensure timely completion of country and site activation requirements.
• Collaborate closely with Regulatory Affairs, Clinical Operations, study teams, vendors, and external stakeholders.
• Support the planning and coordination of regulatory and ethics approval activities, ensuring submission readiness and compliance.
• Provide oversight of study start-up progress, track key metrics, and communicate status updates to stakeholders.
• Contribute to process improvement initiatives and operational excellence activities.
• Review and support essential study documentation and site activation packages.
• Ensure all activities are conducted in compliance with ICH-GCP, local regulations, and company procedures.
   

• Bachelor's degree in Life Sciences or a related discipline.
• 5+ years of experience in clinical research, Study Start-Up, site activation, country start-up, regulatory submissions, or a related field.
• Strong knowledge of UK and European clinical trial start-up processes and regulatory requirements.
• Demonstrated experience performing or coordinating country start-up and regulatory/ethics submissions across the UK and Europe.
• Experience using relevant clinical trial application systems and submission platforms, including CTIS and country-specific systems where applicable.
• Strong understanding of requirements for setting up and activating clinical trial sites, including regulatory, ethics, contractual, feasibility, and operational considerations.
• Experience coordinating country and site activation activities within a clinical trial environment.
• Understanding of Ethics Committee, Regulatory Authority, and site start-up processes.
• Strong project management skills, with the ability to manage multiple studies, priorities, timelines, risks, and stakeholders simultaneously.
• Proven stakeholder management skills and the ability to work cross-functionally with Regulatory Affairs, Clinical Operations, study teams, vendors, and external stakeholders.
• Excellent communication, organisational, and problem-solving skills.
• Fluent English.
   

• Experience leading or coordinating country start-up activities across the UK and multiple European countries.
• Project Management experience of study portfolios or clinical trial programmes.
• Knowledge of UK Combined Review processes and European regulatory pathways.
• Experience working with CTIS, Ethics Committees, Regulatory Authorities, and systems used to support study start-up activities.
• Practical understanding of country and site activation requirements, critical path activities, and study start-up performance metrics.
• Experience working within a sponsor-dedicated or Functional Service Provider (FSP) model.
• Experience driving process improvements and operational excellence initiatives within a clinical trial environment.
• Strong cross-functional collaboration skills within a matrix environment.
   

• This position is an individual contributor role and does not include line management responsibilities.
• The role focuses on coordination, oversight, and delivery of Study Start-Up activities, working closely with specialist functional teams.
• The position is primarily focused on UK and European study start-up activities.
• The role is requires strong practical knowledge of country start-up, UK and EU Regulatory and Ethics submissions, site set-up requirements, and study start up, project delivery.
   

• Work in dedicated partnership with a leading pharmaceutical sponsor.
• Play an important role in delivering clinical trials across the UK and Europe.
• Collaborate with experienced Study Start-Up, Regulatory, and Clinical Operations professionals.
• Contribute to process improvements and operational excellence initiatives.
• Build your career within a global clinical research organization while maintaining a strong regional focus.

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