What are the responsibilities and job description for the Clinical Research Lead position at Radiometer?
Radiometer is a leading provider of diagnostic solutions for life sciences, diagnostics and biotechnology. Our mission is to improve global healthcare with reliable, fast, and easy patient diagnoses.
As a Senior Clinical Study Manager at Radiometer, you will be responsible for overseeing all aspects of clinical trials, including developing and implementing study protocols and monitoring plans, selecting clinical sites, driving timelines in coordination with the clinical monitoring team, ensuring compliance with Standard Operating Procedures (SOPs) and regulatory requirements, and providing regular study progress communication and escalating issues.
This role reports to the Sr. Manager or Director of Clinical Affairs and is part of the Clinical Affairs department. The successful candidate will have the opportunity to work on various clinical projects, collaborating with internal stakeholders and external partners to ensure timely delivery of high-quality results.
The essential requirements of the job include:
- Bachelor's Degree in a relevant field with 9 years of experience, OR Master's Degree with 7 years of experience, OR Doctorate/PhD degree with 4 years of experience
- Knowledge and experience with Good Clinical Practices (GCP) and global IVD, medical device regulations
- Demonstrated agility with processes and details, ability to apply critically thinking, analyze data, and solve complex problems
- Strong work ethic, ability to work independently, and demonstrated ability to deliver assignments on time, and effectively communicate and escalate
- Proficiency in Microsoft Office applications (PowerPoint, Excel, Word)
Additional desirable skills and qualifications include knowledge of CLSI guidelines, GCP, GLP, EDC, and eTMF, as well as clinical research certification (e.g., SOCRA, CCRA, CCRC). Experience with studies involving US FDA submissions and international settings is also highly valued.
