Clinical Lead II/III- Rare Disease

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. 
             

We’re looking for a Clinical Lead II/III- Rare Disease  to join our Clinical Management  team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and 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.

    

What you’ll be doing:              

• Provides coaching and mentoring to clinical staff, study team and external stakeholders and act as Ambassador for Clinical Management Group to internal and external stakeholders
• Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
• Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
• Drive the successful activation of trial sites according to time, quality/scope and budget parameters
• Plan and drive 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 milestone.
• Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
• Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
• Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
• Actively participate in Bid Defense activities