Clinical Lead II (United States)
Premier Research is looking for a Clinical Lead II 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 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:
- Driving and managing the clinical components of the Start up process from site ID to qualification and site activation.
- Training and management of the CRA team for the lifecycle of project, including: Monitoring visit forecasting/resource management; Adherence to the protocol, SOPs/regulations and project plans; Ensuring data quality and patient safety
- Creates and maintains, in a timely fashion, study specific clinical monitoring plans (CMP) utilizing approved templates ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
- 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
- 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
- Apply a risk-based quality management mindset in order to proactively mitigate issues and also provide support for study audits and responses
What we are searching for:
- Bachelor's degree, or local equivalent, in a clinical, biological, scientific, or health-related field
- 5+ years of clinical research/monitoring experience is preferred
- 1+ years of previous Clinical Oversight experience (clinical trial manager) within a Clinical Research Organization
- French speaking fluency required
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 cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the 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.