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Manager, Clinical Studies
Published on: Oct 17, 2024
Country: United States
Location: Austin, Texas
Job Category: Research & Development
Employment type: Regular Full Time
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.
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