Premier Research is looking for a Clinical Lead II (Cell & Gene Therapy) to join our Global 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 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 Biotech™.
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, of which at least 3 years onsite monitoring or 4 years remote monitoring experience is required
- 2-3 years of experience as Clinical Lead (Clinical Trial Management)
- Cell and Gene therapeutic area experience is a priority
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $128,000 USD. The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.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