Director, Study Start Up-EU

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 is looking for a Director, Study Start Up‑EU to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What you'll be doing:

• 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.

What we are looking for:

• Bachelor’s degree, or its international equivalent from an accredited institution, 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.

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life‑changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high – we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.