Director, Study Start Up United Kingdom

Premier Research Group; United States; À distance; USD 120 000 - 173 000; Plein temps

Résumé du poste

Premier Research, a leading CRO, is seeking a Director, Study Start Up in the United Kingdom to lead SSU activities within our Clinical Monitoring, Site Management, and SSU teams. You will oversee regional SSU performance, manage staffing and resources, drive timelines, and partner with senior leaders to implement global efficiencies while ensuring regulatory compliance across regions.

Emphasis on risk management, staff development, and aligning with client needs to deliver high-quality study

Qualifications

• Bachelor’s degree in clinical, scientific or health field.
• 7-9 years of health sciences experience; trials or pharma.
• Direct SSU experience preferred.
• 5-7 years of people management experience.
• ICH/GCP and ISO14155 expertise; regulatory knowledge.
• FDA/EU procedures familiarity.
• Site/institution contract knowledge.

Responsabilités

• Oversee SSU performance and teams in the assigned region.
• Manage staffing and resources for regional utilization.
• Drive SSU teams to meet project timelines.
• Mentor SSU team on knowledge, presentation, accountability.
• Partner with VP to streamline SSU processes and global efficiencies.
• Collaborate with US and other regions to align goals.
• Ensure SSU processes are proactive and per contract.
• Apply risk management principles.

Connaissances

SSU oversight

People management

ICH/GCP knowledge

FDA/EC familiarity

Regulatory compliance

Formation

Bachelor's degree in clinical/health field

Description du poste

Premier Research is looking for a Director, Study Start Up United Kingdom 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.