Clinical Lead II (Rare Disease)

Premier Research is looking for a Clinical Lead II (Rare Disease) to join our Clinical Strategy & Delivery 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 Built for You.
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.
We are Built by You.
Your ideas influence the way we work, and your voice matters here.
We are Built with You.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM.
Join us and build your future here.
What you'll be doing: Drives the successful activation of trial sites according to time, quality/scope and budget parameters Plans and drives both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestones Works cross functionally to deliver project deliverables with PM, Data Managers (DM), and Clinical Monitoring Services team (CMS) Create and maintain in a timely fashion a study specific clinical monitoring plan (CMP) utilizing approved templates; ensure effective communication and escalation instructions are incorporated in the CMP and actioned appropriately Leads, manages and actively monitors the clinical monitoring team with a focus on quality and timely deliverables; addressing any issues with the appropriate team member and their line manager Ensures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues 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 7-9 years of Clinical Research experience 2-3 years of Clinical Lead (Clinical Trial Management) experience Rare Disease therapeutic area experience is preferred Why choose Premier Research? Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
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 opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly.
Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities.
If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway.
You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines.
All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status #LI-CI1