Manager, Clinical Lab Operations

DiaSorin • Austin, TX

78d

About The Position

This position plays an integral role in the development, and maintenance of Clinical Operations Lab and activities timelines in accordance with Luminex PMO timeline. The role involves activities related to the Clinical Operations Lab and 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.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• Developing and maintaining project schedules for Clinical Studies 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), 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 project logistics.
• Supply shipments/tracking.
• Equipment and consumables 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 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.

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees