Job Information
Actalent Clinical Trial Manager in Stillwater, Minnesota
Clinical Trial Manager
The Clinical Trial Manager oversees the clinical trial process for new diagnostic products and supports new and existing products in compliance with IVDR regulations.
The role involves authoring, reviewing, and compiling clinical documentation to support EU IVDR and/or FDA requirements.
Responsibilities include developing clinical trial protocols, establishing capabilities for trial sites, managing contracts, and ensuring compliance.
The position also involves training trial sites and internal departments, coordinating logistics for sample and data transfer, and managing cost accounting.
Post-trial activities include coordinating cross-functional teams to launch new products, ensuring publications and white papers are available, and assisting in premarket positioning.
Periodic travel, both domestic and international, is expected. Compliance with applicable regulations, including ISO, Local, State, and/or Federal requirements, is required.
Hard Skills
+5 years of Clinical Research Experience
+3 years of diagnostics or Pharma
FDA & EUIVDR Experience
Job Type
This is a permanent position.
Work Site
This is a hybrid position requiring some days on-site in Stillwater, Minnesota and some days remote.
Work Environment
This is a Hybrid role. 3 days in office. This individual will be required to travel when needed for SIV and close-out visits. Travel is across the US.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.