Premier Research is looking for a Clinical Lead III 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 BiotechTM. Join us and build your future here.
What you'll be doing:
- Leads and supports initiatives and process improvement work streams within CMG and Clinical Operations Dept.
- Drives the successful activation of trial sites according to time, quality/scope and budget parameters
- 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
- Ensures timely data verification through review of data management reports and use of monitoring resources to optimize monitoring of clinical data (i.e. pending SDV, missing pages, and aging queries)
- Contribute to the risk management plan and contribute to set up of adaptive risk monitoring system with the PM on an ongoing basis in order to mitigate unexpected clinical events in the conduct of the trial
- 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 its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
- 9 years of clinical research experience as a CRA, CL or PM, of which at least 4 years onsite monitoring or 5 years remote monitoring experience is required, or 11 years of clinical research experience as a CRA, CL or PM of which at least 5 years of clinical monitoring experience is required
- 4 or more years of previous Clinical Oversight experience or equivalent; global experience and Neuroscience experience highly preferred
- Expert negotiation and presentation skills
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
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.
