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Diasorin · 1 day ago

Senior Clinical Studies Associate

Stillwater, MN

Full-time

Hybrid

Senior Level

$92K/yr - $112K/yr

5+ years exp

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. The role involves overseeing the clinical trial process for new diagnostic products, including protocol development, site management, and compliance monitoring.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

Responsibilities

In collaboration with other DiaSorin staff, identify potential external sites for the evaluation of new DiaSorin IVDs and performance of clinical trials

Perform detailed investigations, including site visits, to evaluate the technical capability of potential external collaborators

Participate in the development of clinical trial protocols, which will include evaluation of the individual site’s technical and logistical capabilities to perform the protocols

Initiate contract negotiations with external collaborators and present to the appropriate DiaSorin personnel for final signature. Periodically review the sites for contract compliance during the clinical trial process

Coordinate and manage the clinical specimen acquisition process

Coordinate any training required at external collaboration sites, which may include providing on-site training

Act as the primary contact person between DiaSorin and external collaborators for the exchange of information regarding contracts, IRB/HIPPA information, clinical trial instructions, technical data, and reports

Monitor the performance of clinical trial sites by reviewing procedures, personnel and data generated at the sites including period visits to all clinical trial sites

Serve as the coordinator of cross-functional departments and teams such as R&D, manufacturing, Regulatory Affairs, Marketing, and Technical Services to bring products through the regulatory process and launched to the field

Work with the clinical trial sites to ensure clinical trial data is published in peer-reviewed journals or other appropriate platforms

Assist in developing the economical models for the proper positioning of new products for the market

Identify speakers, venues, and other resources for the pre-market positioning of new products

Institute and maintain a cost accounting and management system for external test and clinical trial sites

Research technical questions through review of periodicals, interaction with in-house personnel, the Internet, and any other resource

Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process

Perform other duties as assigned

Qualification

Clinical trial managementIVD experienceLaboratory medicine experienceACRP-CP CertificationProject managementPeople skillsMathematical conceptsCommunication skillsTime management

Required

Bachelor's Degree in Health science or related field required, RN a plus

5+ years' experience in the field of IVD and 5 or more years' experience in laboratory medicine required

The person should have experience and be competent in interacting and communicating with external collaborators and clients

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

The person should have training and experience in laboratory platforms similar to those that will be used in future clinical trials

The position requires the maintenance of documentation to meet specific quality standards

The applicant should have 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, collect 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

Preferred

Master's or Doctorate Degree

ACRP-CP Certification

A background in Medical Technology is not required but would be a definite advantage

Benefits

Comprehensive plan of health benefits

Retirement and financial wellbeing

Time off programs

Wellbeing support and perks

Annual incentive program

Company

Diasorin

Glassdoor3.1

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics

Founded in 1968

Saluggia, Piemonte, ITA

1001-5000 employees

https://www.diasorin.com/

H1B Sponsorship

Diasorin has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)