Clinical Studies Manager - Austin, United States - USA 2021-087

Job Title

Clinical Studies Manager

Job Facts

Organizational Area
USA and Canada
Country / State
United States
Place of work
Austin
Home/Office based
Home based

Professional Family: 

  • Quality
Reporting To
Senior Director

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2021-087

Job Scope

Your Mission

For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.

Main Responsibilities

Your Contributions

We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.

We have a need for a Clinical Studies Manager with a strong background in research and regulatory environment. This 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. Make an impact where your background and experience will ensure our diagnostic tests continue to impact patients’ lives for many years to come.

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
B.S. degree in Molecular Biology, Biochemistry or related discipline with at least 4 years related experience required. Master’s degree preferred
Experience

Showcase your clinical expertise as you develop a skilled group of Clinical Research Associates to select and manage clinical study sites; participate in clinical trial study design and analysis of clinical trial data. Your biostats and validation background will come in handy as well as your experience working in the medical diagnostics device field. This is an amazing opportunity to contribute to the continued growth of a successful organization while growing your career. Leverage your excellent communication, project management, time management, and people skills as you build relationship within the organization.

Technical Competencies

• B.S. degree in Molecular Biology, Biochemistry or related discipline with at least 4 years related experience required. Master’s degree preferred
• Experience in laboratory platforms similar to those that will be used in future clinical trials
• A background in Medical Technology would be a definite advantage
• Technical product expertise with various diagnostic products and delivery platforms is preferred

Skills

• High competence in interacting and communicating with internal & external collaborators
• Strong attention to detail
• Excellent project management, data analysis, time management and people skills with a sense of urgency
• Strong background using Microsoft Office Suite

Languages
English
Travel Availability
Yes
Relocation Availability
N/A
Training Required

Yes

Benefits

We Offer You

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.

Others Information as per Local Legal Requirements

This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(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. Equal Employment Opportunity Posters: https://www.dol.gov/agencies/ofccp/posters.
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email: hrtalent@diasorin.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail: hrtalent@diasorin.com or call toll-free 1.800.328.1482