Manager, Clinical Operations

Published on: Sep 29, 2025

Country: United States

Location: Austin, Texas

Company: Luminex Corporation

Job Category: Research & Development

Employment type: Regular Full Time

Req ID: 7210

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

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.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

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

This position plays an integral role in the development, and maintenance of Clinical studies and activities timelines in accordance with Luminex PMO timeline requirements as well as administrative role related to CTMS. The role involves activities related to the logistical requirements for the execution of clinical studies in accordance with applicable global regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.

Key Duties and Responsibilities

Developing and maintaining project schedules for Clinical Affairs activities with a standard PMO (project management organization) approach.
Assigning action items and managing logistics in order to meet these schedule deadlines.
Working closely with CROs (contract research organizations), contracted data management teams, Clinical Affairs, the Clinical Trial Managers, Sample Bank team, Legal department, Logistics team, and Marketing teams to ensure project tasks are managed to completion.
Overseeing equipment and supply inventory for Clinical Operations Laboratory
Assist in design and conduct of studies and clinical trials conducted within the Clinical Operations Laboratory
Directly manage Clinical Operations Project Coordinator(s)
Directly manage project logistics:
Supply shipments/tracking
Control shipments/tracking
Instrument and equipment ordering, shipments/tracking
Development of any tracking tools or logs needed for logistics
Develop of departmental SOPs
Manage resources, time, and expenses in alignment with business priorities
Manage and maintain CTMS (clinical trial management software) administration
Manage installation and maintenance of equipment in Clinical Operations Lab
Manage ordering of supplies and materials for the Clinical Operations Lab and clinical trials
Assist in the design and conduct experiments in the laboratory and analyze scientific data in accordance with Good Laboratory Practices
Assist in writing protocols and reports relating to verification and validation of molecular tests and quality system elements
Any other duties deemed necessary by management

Education, Experience and Qualifications

Bachelor's Degree with 5 years’ of laboratory experience required. required or
Master's Degree with 3 years’ of laboratory experience required. preferred
1+ Years PMO experience preferred
1+ Years Experience managing or leading teams required

Training and Skills

Superior communication, presentation and writing skills
Highly organized with proven time management and prioritization skills
Experience in molecular biology tools and techniques
Experience in searching through and understanding scientific and regulatory literature
Experience in working independently in a fast-paced environment with rapidly changing priorities
Experience in documentation and record management for laboratory and clinical studies (GLP and GCP)
Experience or knowledge of the requirements on working in a FDA regulated environment

Travel Requirements

20% Domestic
10% International

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 hrtalent@diasorin.com or 1-800-328-1482 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.