Clinical Lead III
Description
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 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:
- Provides coaching and mentoring to clinical staff, study team and external stakeholders and serve as initial point of contact and Ambassador for Clinical Management Group to internal and external stakeholders
- Leads, manages and actively monitors the clinical monitoring team with a focus on ensuring quality and timely deliverables, addressing any issues with the appropriate team member and their line manager
- Drives the successful activation of trial sites according to time, quality/scope and budget parameters, including completing/contributing to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites and applying clinical and monitoring expertise in the design of case report forms
- Create and maintain in a timely fashion a study specific clinical monitoring plan (CMP), tracking and analyzing open actions, protocol deviations and assessing the financial health of the clinical aspect of the study ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
- Engages cross functionally to deliver project deliverables with PM, Data Managers (DM), Clinical Monitoring Services team (CMS) to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk; plan and drive both patient recruitment and retention; ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues; establish clinical project timelines and accomplish all milestones throughout the study; and assist in the creation and maintenance of the Trial Master File
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
- 9 years+ of previous Clinical Oversight experience as a Clinical Lead
- 4 years + of onsite monitoring experience
- Rare Disease/Pediatrics experience is preferred
- Working knowledge of clinical financials including understanding of budgets, pass-through and resource management
- Experience on the CRO side 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-EC1