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As Director, Study Start Up-EU, you lead the SSU group across assigned regions to enable timely, compliant study initiation. You partner with Clinical Leadership, PM and Business Development to align delivery with client contracts and drive operational excellence. You implement global process improvements, develop training materials and own risk management for SSU activities.

You play a pivotal role in shaping the department’s performance, timelines and cross-region consistency. Your leadership accelerates medical innovation that improves patient outcomes.

Compensaciones / Beneficios

- Lead and develop SSU teams (SSUAs and SSUA Managers) to deliver on regional timelines
- Manage initial essential document collection, EC/IRB submissions, site initiation and EC submissions as applicable
- Oversee staffing, resource allocation and regional utilization to meet project needs
- Collaborate with PM,



Clinical Leadership and BD to manage contracts and client expectations
- Drive integral process improvements and develop training materials
- monitor departmental metrics and ensure alignment with business initiatives
- Identify and mitigate risks, investigate root causes, and escalate where necessary
- Ensure proactive SSU processes are completed per contract and maintain SOP/WG/AD reviews

Responsabilidades

- Bachelor's xugodme degree in a clinical, scientific or health related field
- 7-9 years in health sciences or clinical trials support
- Direct experience in study start up roles preferred
- 5-7 years of personnel management experience
- Expertise in ICH/GCP and ISO14155
- Working knowledge of FDA and European regulatory procedures and site contracts
- Knowledge of country-specific regulatory drug/device Ru0026D requirements

Requisitos principales

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📌 Director, Study Start Up-Poland (España)
🏢 Premier Research
📍 España