Senior Clinical Studies Associate
3 weeks ago
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
- Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
- Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact
Job Scope
The position oversees the clinical trial process for new diagnostic products and supports new and existing products in compliance with IVDR regulations. Candidates will be responsible to author, review and compile clinical documentation to support EU IVDR and/or FDA requirements.
Activities may include 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 premarket 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 productsthrough 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.
Other Duties and Responsibilities
- 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.
- Requires Bachelor's degree with a minimum of 5 years experience in the field of IVD and 5 or more years experience in laboratory medicine.
- The person should have experience and be competent in interacting and communicating with external collaborators and clients.
- 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
Receive a competitive salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world.
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at or to request an accommodation.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
This contractor and subcontractor shall abide by the requirements of 41 CFR a), 41 CFR a) and 41 CFR a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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