Overview

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As Director, Study Start Up-EU you lead the SSU group across the region, aligning strategy with project delivery and client expectations. You’ll partner with PM, Clinical Leadership and Business Development to ensure smooth regulatory submissions, site activation and contract alignment. You drive operational excellence, manage risk, and develop staff while delivering on regional metrics. This role offers influence over process improvements, training, and cross-regional collaboration to accelerate medical innovation. You will shape how SSU supports patients by enabling timely study start-up in a complex regulatory landscape.

Responsabilidades

- Lead the Study Start Up (SSU) group in the assigned region(s) and drive business strategy aligned to project delivery
- Performance manage and develop SSU staff; ensure departmental utilization and staffing for new studies
- Collaborate with Project Management, Clinical Leadership and Business Development to manage contractual agreements and client expectations
- Oversee SSU activities: initial essential documents, EC/IRB submissions, site initiation, ethical committee submissions, and coordination with site teams
- Identify general process improvements, develop training materials, and maintain consistency across the department
- Manage metrics to support business initiatives and ensure timely project delivery
- Provide risk management, issue escalation,



and proactive problem solving for complex time-sensitive issues
- Oversee SSU performance and regional teams; participate in resource planning for new studies
- Partner with VP to improve, streamline, and apply global SSU efficiencies and processes
- Collaborate with US and other regions to align goals and ensure proactive, contract-compliant SSU processes
- Contribute to business development through evaluating proposal specifications and participating in monthly metric reporting
- Mentor direct reports, oversee training and career development, and ensure smooth transition planning for staff changes
- Review applicable SOPs, WGs and ADs related to SSU; share knowledge with other managers
- Produce succinct internal and external documentation and presentations with minimal upper-management input xcgbitx

Requisitos principales

- Bachelor in Clinical, Scientific or Health-related field
- 7-9 years of related health sciences experience; clinical trials support or pharmaceutical industry preferred
- Direct experience in study start up roles
- 5-7 years of personnel management experience overseeing larger teams
- Expertise in ICH/GCP and/or ISO14155 and country-specific regulatory requirements for clinical trials
- Working knowledge of FDA, European Regulatory and EC procedures
- Knowledge of site and institution contract requirements

- leadership
- cross-functional collaboration
- risk management
- ICH/GCP
- ISO14155
- EC submissions and regulatory compliance

📌 Director, Study Start Up-EU - españa (Formentera)
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