Leads study start-up performance and teams across the United Kingdom, managing staffing, resources, utilization, timelines, process efficiency, contractual compliance, and risk management. Collaborates with global SSU leadership to standardize processes and improve team capabilities. Requires clinical or scientific expertise, substantial clinical trials or pharmaceutical industry experience, personnel management experience, and detailed knowledge of ICH/GCP, ISO 14155, FDA, European, and country-specific regulatory requirements.
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.
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