Clinical Study Manager

Published on: Nov 15, 2024

Country: United States

Location: Austin, Texas

Company: DiaSorin Molecular LLC

Job Category: Research & Development

Employment type: Regular Full Time

Req ID: 6567

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

The Clinical Studies Manager will be responsible for:

Managing clinical study activities at Luminex. Coordinating clinical studies, from qualifications of clinical study sites through monitoring of clinical study activities and completion of clinical trials. Ensuring that clinical studies are executed in compliance to applicable regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH). Writing of study protocols, reports, SOPs and other documents.

Key Duties and Responsibilities

Manage the planning and execution of clinical studies, including data collection activities

Play a leading role in the qualification of clinical trial sites

Coordinate collection and tracking of clinical study specimens

Participate in clinical site training, monitoring, and support

Play a role in the analysis and interpretation of clinical trial data

Establish scientific methods for design and implementation of study protocols and data collection systems that meet quality and regulatory requirements

Prepare clinical study final reports

Monitor adherence to protocols during clinical studies and determine study completion

Participate in project core teams by presenting clinical study status updates and data, as appropriate

Manage clinical trial resources and timelines in coordination with project core teams

Interact with various internal/external groups to facilitate completion of studies for inclusion in regulatory submissions for in vitro diagnostic devices

Conform to applicable regulations and standards and company quality policies
Other duties as assigned.

Education, Experience, and Qualifications

Ph.D. or Master's Degree in Molecular Biology, Biochemistry or related discipline with at least 3 years’ related experience required or Bachelor's Degree in Molecular Biology, Biochemistry or related discipline with at least 6 years’ related experience required

4-6 Years clinical studies experience required

Training & work experience in document and record management for clinical study (GCP) required

Experience in a GMP and/or FDA regulated environment required

Experience working independently in a fast-paced environment with rapidly changing priorities required

Training and Skills

Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors

Can exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

Must have good understanding of 21 CFR Part 812 regulations and CLSI guidelines

Excellent interpersonal skills with proven ability to work both in a team-oriented environment and independently

Excellent verbal and written communication skills

Strong organizational skills

Exceptional time management and prioritization skills

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.