Job Scope

The position oversees the clinical trial process for new diagnostic products. The process includes participating in the development of clinical trial protocols, establishing the capabilities required for the clinical trial sites to complete the protocols, identifying sites having the proper clinical trial capabilities, managing the clinical trial contract process, and managing the clinical trial sites for compliance. Training of clinical trial sites and internal departments such as Technical Services may be required. Coordinating the logistics of sample and data transfer as well as cost accounting of the clinical trial process will be performed. The post-clinical trial activities of this position include coordinating cross-functional teams to launch a new product or device, ensure publications and white papers are available, and assist in the pre-market positioning of the new product. The clinical trial sites may be either domestic or international, so periodic field travel can be expected. Supports applicable regulations including ISO, Local, State, and/or Federal requirements.

Key Duties and 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.

Education, Experience and Qualifications

• Bachelor's Degree (RN a plus) Required
• Advanced Degree, e.g., Master or Doctorate Preferred
• 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. Required
• ACRP-CP Certification Preferred
• 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.
• A background in Medical Technology is not required but would be a definite advantage.
• 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, 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.

What we offer

The hiring range for this position is $87,500-$108,000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.