Description
At IQVIA, our Clinical Functional Service Partnership (CFSP) models offer the best of both worlds: the opportunity to work as an integrated member of a leading sponsor's team while benefiting from the global expertise, career development and support of IQVIA.
As a Regulatory and Start-Up Specialist, you will play a critical role in bringing clinical trials to life. Working within a sponsor-dedicated environment, you will manage site identification, regulatory submissions, ethics approvals and site activation activities that help studies start faster and accelerate patient access to innovative treatments.
Key Responsibilities
- Serve as the primary point of contact for investigative sites, Site Activation Managers, Project Managers and internal stakeholders.
- Execute site identification, feasibility assessment, and site activation activities for assigned clinical studies.
- Prepare, review, and distribute regulatory documentation to ensure completeness, accuracy, and compliance.
- Track and manage submission, approval, and execution of essential documents.
- Review, negotiate, and manage site regulatory documents, contracts, and associated start-up deliverables.
- Maintain accurate records within internal systems and tracking tools.
- Monitor project milestones and proactively identify risks and mitigation plans.
- Provide local regulatory expertise to project teams and Site Activation Managers.
- Perform quality reviews of site documentation.
- Review site performance metrics and contribute to continuous process improvement initiatives.
- Collaborate closely with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery.
What We're Looking For
- Bachelor's Degree in Life Sciences or a related scientific discipline.
- Experience in clinical trial regulatory affairs, site start-up, site activation, or related clinical research functions.
- Strong understanding of local and international regulatory requirements, GCP, and clinical research processes.
- Experience managing regulatory documentation, contracts, and start-up deliverables.
- Excellent communication, negotiation, and problem-solving capabilities.
- Fluency in Dutch with strong English communication skills.