Clinical Study Manager

KPS Life; Utrecht; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

KPS Life is seeking a Clinical Study Manager to join the Global Clinical Research team at Utrecht. This sponsor-dedicated, 6-month contract role involves the operational management of clinical studies from start-up through execution, in full compliance with the Clinical Study Plan, ICH-GCP, regulations, and internal SOPs.

You will lead start-up and ongoing operations for complex studies, collaborating with researchers, data management, CROs, and sites, ensuring timelines, budgets, and resources

Qualifications

• Master’s degree or PhD in Life Sciences or related discipline.
• 5+ years of experience in international clinical research, sponsor side preferred.
• Solid knowledge of ICH-GCP and applicable legislation.
• Strong project management and leadership skills.
• Proactive problem-solving mindset with ability to handle complex challenges.
• Ability to lead studies across all stages while translating regulatory requirements into pragmatic, risk-conscious approaches.

Responsibilities

• Lead the operational setup and management of clinical studies from start-up to close-out.
• Build and maintain effective collaboration within multi-disciplinary project teams (Researchers, Clinical Study Assistants, Data Management, Supplies, Statistics, Quality, and Science).
• Ensure all studies are conducted in accordance with ICH-GCP and applicable legislation.
• Manage regulatory and ethics submissions and approvals.
• Select, oversee, and monitor external partners (CROs, CRAs, sites).
• Provide regular progress reporting on resources, budgets, and timelines.
• Contribute to business strategy and translate it into project execution.
• Drive process improvements and innovation within the team.

Skills

Project management

Leadership

Stakeholder influence

Regulatory knowledge

Education

Master’s degree or PhD in Life Sciences

Job description

KPS is looking for a Clinical Study Manager to join the Global Clinical Research team. This is a sponsor-dedicated, 6-month contract role with a hybrid working model requiring 2 days per week in the Utrecht office .

Your mission

As Clinical Study Manager, you will be responsible for the operational management of clinical research projects - from start-up through execution - in full compliance with the Clinical Study Plan, ICH-GCP, applicable regulations, and internal SOPs.

You will play a key role in the start-up and day-to-day operational leadership of (complex) clinical studies, supporting the Senior Team Leader while driving deliverables, delegating tasks, and implementing improvements across the team and projects.

Key responsibilities

• Lead the operational setup and management of clinical studies from start-up to close-out
• Build and maintain effective collaboration within multi-disciplinary project teams (Researchers, Clinical Study Assistants, Data Management, Supplies, Statistics, Quality, and Science)
• Ensure all studies are conducted in accordance with ICH-GCP and applicable legislation
• Manage regulatory and ethics submissions and approvals
• Select, oversee, and monitor external partners (CROs, CRAs, sites)
• Provide regular progress reporting on resources, budgets, and timelines
• Contribute to business strategy and translate it into project execution
• Drive process improvements and innovation within the team

We are looking for

• Master’s degree or PhD in Life Sciences or a related scientific discipline
• Minimum 5 years of experience in international clinical research, preferably from the sponsor side
• Solid knowledge of ICH-GCP and relevant legislation
• Strong project management and leadership skills
• Proactive problem-solving mindset with the ability to handle complex challenges
• Demonstrated ability to lead studies across all stages while translating regulatory requirements into pragmatic, risk-conscious approaches

The ideal candidate is comfortable influencing both internal stakeholders and external partners (CROs, central labs, sites, investigators, and Key Opinion Leaders), shows clear leadership, and actively contributes to improving team ways of working.

• 6-month contract (sponsor dedicated)
• Hybrid role - minimum 2 days per week in the Utrecht office is required