Study Start-Up Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Manager, Study Start-Up to join our diverse and dynamic team. This role is responsible for ensuring the performance and compliance of assigned clinical trial protocols within a country, in alignment with ICH/GCP guidelines, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

Under the oversight of Senior Managers, the role holds accountability for country-level budget and financial management, as well as the execution and oversight of clinical trial submissions and regulatory approvals. The position also ensures sites are fully prepared and “site ready” to support timely study start-up and delivery.

This is a sponsor-dedicated role based in the Amsterdam region, offering flexible homeworking options. The position is offered as a one-year contract with the potential for extension or conversion to a permanent role.

What You Will Be Doing:

In this role, you will lead and oversee country-level clinical trial operations, ensuring efficient execution, compliance, and delivery of study objectives. Responsibilities include, but are not limited to:

• Budget & Contracts: Own country and site budgets, including the development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs).
• Financial Oversight: Manage and track clinical research payments, including reconciliation at study close-out. Ensure compliance with applicable financial regulations (e.g., FCPA, DPS/OFAC) and contribute to financial forecasting in collaboration with cross-functional partners.
• Regulatory Submissions: Lead country-level submissions and approvals for assigned clinical trial protocols, ensuring alignment with regulatory requirements.
• Local Documentation: Develop and manage local-language study materials, including informed consent forms and translations; serve as a key liaison with IRB/IEC and Regulatory Authorities.
• Study Execution: Oversee country deliverables, timelines, and results to ensure studies are delivered on time, within scope, and in compliance with quality standards.
• Process Improvement: Contribute to the development and implementation of local standard operating procedures (SOPs); provide oversight to Clinical Trial Coordinators (CTCs), as applicable.
• Cross-Functional Collaboration: Partner with internal stakeholders (e.g., CRM, CRA, Finance, Legal) to ensure timely completion of submissions, budgets, contracts, and key milestones.
• Global Alignment: Collaborate closely with headquarters to align on timelines, priorities, and study execution strategies.
• Vendor Management: Provide oversight and support to local vendors to ensure quality and performance expectations are met.
• Operational Management: Oversee local clinical operations, including supply management, import/export requirements, documentation, archiving, retention, and insurance processes; maintain accurate data in clinical and financial systems.
• Compliance & Governance: Ensure adherence to local regulatory and financial requirements, playing a critical role in successful study start-up and execution.
• Stakeholder Influence: Engage and influence investigators, external partners, and internal teams to meet budget targets and agreed timelines.
• Partnerships: Collaborate across functions including GCTO country operations, regulatory affairs, pharmacovigilance, finance, legal, and regional teams, as well as external partners such as vendors, sites, and regulatory bodies.
• Team Development: Support team growth by mentoring colleagues and sharing best practices.

Your Profile:

• Bachelor’s degree in life sciences, clinical research, or a related field. Advanced degree or project management certification is a plus.
• Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations.
• Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment.
• Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously.
• Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams.
• Experience with process optimization and implementing best practices in study start-up activities.

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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Global contract research organization providing outsourced clinical development services. Headquartered in Dublin, Ireland.

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