What are the responsibilities and job description for the Senior Clinical Study Manager position at Radiometer?
Accelerate Your Potential in Life Sciences, Diagnostics and Biotechnology
At Radiometer, a Danaher company, our mission is to innovate for tangible impact and improve patient care. We're united by a shared commitment to harness the power of life sciences, diagnostics, and biotechnology to make a real difference.
Our Culture
You'll thrive in a culture of belonging where your unique viewpoint matters. Our team values diversity, inclusivity, and continuous improvement. We believe that everyone deserves to be heard, supported, and empowered to succeed.
Our Vision
At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We're proud to work alongside a community of six fellow Diagnostics Companies at Danaher to address the world's biggest health challenges.
Job Summary
The Senior Clinical Study Manager will oversee all aspects of a clinical trial, including developing and implementing study protocols and monitoring plans, selecting clinical sites, driving timelines, ensuring compliance with SOP and regulatory requirements, and providing regular study progress communication.
Key Responsibilities:
- Drive clinical schedule deliverables to meet project timelines
- Proactively identify clinical project risks and develop countermeasures
- Collaborate with cross-functional teams and external partners on study deliverables
- Participate in shaping clinical study design and completion of study planning deliverables
Requirements:
- Bachelor's Degree in 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 GCP and global IVD, medical device regulations
- Demonstrated agility with processes and details, ability to apply critically thinking, analyze data (using analytical tools), and solve complex problems
Travel and Environment Requirements:
- Able to travel up to 10-25% regionally and internationally
Preferred Qualifications:
- Knowledge of CLSI guidelines, GCP, GLP, EDC, and eTMF
- Clinical research certification (i.e., SOCRA, CCRA, CCRC)
