Premier Research is looking for a Clinical Lead II - Neurology to join our Clinical Management 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:
- Significantly contributes to the KOM meeting to ensure a strong and aligned SSU and clinical delivery strategy and the proposed study budget aligns with execution expectations of the customer. Effectively leads large clinical/SSU teams.
- Significantly contributes to the Risk Assessment meeting to identify any protocol execution risks or other Clinical/SSU operational risks.
- Contributes to cross functional strategy and problem solving by collaborating with PM and other support functions to ensure clinical systems are set up, UAT’s, maintained and supports project and reporting needs.
- Collaborates with SSU team (eg Regulatory Submissions Leads, Site Start Up Associates, Contracts Leads/Specialists, and/or Site Activation Leads) to ensure sites are identified, selected, approved by authorities’/ethics committees and activated within the specified timeline/budget.
- Plans/oversees patient recruitment and retention strategies. Partners with CRAs to drive individual site enrolment targets.
What we're searching for:
- Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
- 2 years of experience as a Clinical Lead, preferably gained in a CRO environment. Prior onsite monitoring experience including experience with Risk-Based Monitoring is preferred.
- Neurology experience is essential and should ideally have been gained in a Clinical Lead capacity vs solely as a CRA albeit candidates with extensive Neurology CRA or Coordinator experience and / or a degree (or equivalent) specifically in Psychiatry / Neurology may also be considered.
- Strong knowledge on global processes and regulations
- Strong understanding of other functional processes including QA.
- Excellent communication, presentation, and soft skills to manage teams and sites effectively.
- Strong leadership skills including organizational skills, ability to persuade and motivate team members and sites to achieve targets.
