Senior Clinical Studies Associate
$87,500–$108,000 year
On-siteStillwater, Minnesota, United States
Job Summary
Oversee the clinical trial process for new diagnostic products by identifying external sites, evaluating their technical capabilities, and managing contract negotiations. Participate in protocol development, coordinate specimen acquisition, and conduct site visits to monitor performance and compliance with regulatory standards. Serve as the primary liaison for information exchange regarding contracts, IRB, and clinical instructions while coordinating cross-functional teams to launch products and ensure data publication. Manage cost accounting systems and provide on-site training where required. Periodic field travel is expected for domestic and international site management.
Required Qualifications
- Bachelor's Degree (RN a plus)
- 5+ Years experience in the field of IVD
- 5 or more years' experience in laboratory medicine
- experience and be competent in interacting and communicating with external collaborators and clients
Desired Qualifications
- Advanced Degree, e.g., Master or Doctorate
- ACRP-CP Certification
- Senior Clinical Affairs Specialist, North America should be knowledgeable of and technically competent with all of DiaSorin's products in development and slated for clinical trials
- training and experience in laboratory platforms similar to those that will be used in future clinical trials
- A background in Medical Technology
- excellent communication, project management, time management, and people skills
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
- Ability to work with mathematical concepts such as probability and statistical inference
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Ability to define problems, collects data, establish facts, and draw valid conclusions
- Ability to interpret extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
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