EU Study Start-Up Director: Lead Trials & SSU

61 Premier Research Poland Sp. z.o.o; Polska; On-site; PLN 380,000 - 580,000; Full time

Job summary

Premier Research Poland Sp. z.o.o. is seeking a Director, Study Start Up‑EU to lead SSU activities within the Clinical Monitoring, Site Management and SSU teams.

You will oversee regional performance, resource planning, and timelines to ensure successful study start up across Europe. In this role you will work closely with global stakeholders, ensure compliance with ICH/GCP and regional regulatory requirements, and mentor SSU staff to enhance expertise and accountability in a fast‑paced

Qualifications

• Bachelor’s degree, or its international equivalent, in a clinical, scientific or health related field.
• 7-9 years of related experience (health sciences); clinical trials support or pharmaceutical industry experience preferred.
• Direct experience in study start up roles highly preferred.
• 5-7 years of personnel management, oversight of larger groups preferred.
• Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory drug/device research and development requirements for conducting clinical trials.
• Working knowledge of FDA, European Regulatory and EC procedures as applicable.
• Knowledge of site and institution specific contract requirements.

Responsibilities

• Provides immediate oversight for the SSU performance and teams within the assigned region/s.
• Manages staffing, and resources to ensure departmental utilization within region.
• Drives SSU teams to meet project timelines.
• Helps the SSU team to improve about their job knowledge, presentation skills and accountability.
• Partners with VP to determine, improve, streamline, and apply global efficiencies and processes for SSU.
• Closely collaborates with the SSU mgmt. within the US and in other regions to work towards same goals, objectives in a consistent manner.
• Ensures that the SSU process is proactive and completed according to contractual agreement.
• Exercises principles of risk management.

Job description

Premier Research Poland Sp. z.o.o. is seeking a Director, Study Start Up‑EU to lead SSU activities within the Clinical Monitoring, Site Management and SSU teams.

You will oversee regional performance, resource planning, and timelines to ensure successful study start up across Europe. In this role you will work closely with global stakeholders, ensure compliance with ICH/GCP and regional regulatory requirements, and mentor SSU staff to enhance expertise and accountability in a fast‑paced