Senior Study Start-Up Director, Poland

61 Premier Research Poland Sp. z.o.o; Poland; On-site; PLN 350,000 - 700,000; Full time

Job summary

Premier Research Poland Sp. z.o.o seeks a Director of Study Start Up to oversee SSU teams in Poland and adjacent regions. You will drive timelines, manage staffing, and partner with the VP to streamline global SSU processes while ensuring contract compliance and risk controls.

You will bring extensive SSU experience, strong regulatory knowledge, and a proven ability to lead diverse teams across borders. This role offers leadership in an international clinical research environment.

Qualifications

• Bachelor’s degree in a clinical, scientific or health field.
• 7–9 years of health sciences experience; trials support or pharma preferred.
• Direct SSU experience is highly preferred.
• 5–7 years of personnel management experience.
• Expertise in ICH/GCP and ISO14155 requirements.
• Knowledge of FDA and European regulatory procedures.

Responsibilities

• Provide oversight for SSU performance and teams in the region.
• Manage staffing and resources to ensure regional utilization.
• Drive SSU teams to meet project timelines.
• Help SSU staff improve knowledge, presentation, accountability.
• Collaborate with VP to improve global SSU efficiencies.
• Coordinate with US and other regions to align goals.
• Ensure SSU processes are proactive and contract‑compliant.
• Apply risk management principles across SSU operations.

Skills

SSU leadership

Project oversight

Regulatory knowledge

People management

ICH/GCP

FDA/EU procedures

Education

Bachelor's degree in clinical/scientific/health field

Job description

Premier Research Poland Sp. z.o.o seeks a Director of Study Start Up to oversee SSU teams in Poland and adjacent regions. You will drive timelines, manage staffing, and partner with the VP to streamline global SSU processes while ensuring contract compliance and risk controls.

You will bring extensive SSU experience, strong regulatory knowledge, and a proven ability to lead diverse teams across borders. This role offers leadership in an international clinical research environment.