Director, Study Start Up-EU (Clinical Trials)

Location: Poland

Company

hirify.global supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.

What you will do

• Lead Study Start Up teams within the assigned European region or regions.
• Oversee essential document collection, EC/IRB submissions, site initiation, and study start-up activities.
• Manage staffing, resources, utilization, timelines, departmental metrics, and study transitions.
• Partner with Project Management, Clinical Leadership, Business Development, and regional SSU management to align delivery and client expectations.
• Identify risks and root causes, apply risk-management principles, and resolve or escalate complex issues.
• Drive global process improvements, training materials, productivity initiatives, and proposal activities.

Requirements

• Bachelor’s degree or international equivalent in a clinical, scientific, or health-related field.
• 7–9 years of related health sciences experience; clinical trials support or pharmaceutical industry experience is preferred.
• Direct experience in study start-up roles is highly preferred.
• 5–7 years of personnel management experience, preferably overseeing larger groups.
• Expertise in ICH/GCP and/or ISO 14155, including country-specific regulatory requirements for clinical trials.
• Knowledge of FDA, European regulatory, EC procedures, and site- and institution-specific contract requirements.

Culture & Benefits

• Opportunities for professional growth, skill development, and career advancement.
• Flexibility and balance to support personal and professional needs.
• Collaborative work across clinical monitoring, site management, study start-up, project management, and business development teams.
• Employee input contributes to working methods and process improvements.