Senior Medical Monitor, Medical Affairs (Oncology)

Medical ManagementRemote, United States


Position at Premier Research

Premier Research is looking for a Senior Medical Monitor (Oncology) to join our Medical 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 BiotechSM. Join us and build your future here.             
What you'll be doing:                
  • Conducts medical data review and generates data queries 
  • Initiates medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements. 
  • Writes and reviews Medical Monitoring Plans. 
  • Processes and addresses protocol non-compliances at Investigative sites and ensures adherence to ethical guidelines 
  • Attends Investigator Meetings and interacts with Investigative site staff and client representatives 
  • Works closely with Medical Directors/Investigative Sites/CRAs to document and assist with resolution of clinical issues, e.g. continuing eligibility queries 
What we are searching for:                 
  • Graduate in medicine
  • Extensive clinical practice experience in oncology is preferred (Board certification or equivalent not required).
  • CRO experience in an alternative function is preferred (e.g. CRA, data management)
  • 5 or more years’ experience of working in a medical or safety department, specifically minimum of 2 years' experience with oncology/hematology studies highly desired
  • Demonstrable expert knowledge of medical terminology and detailed knowledge of medical monitoring processes and regulations and expert experience with medical data review  
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.