Clinical Laboratory Director - CRO - Global Laboratory Services

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Job description

Growing CRO seeks an experienced lab director

This Jobot Job is hosted by: Hunter Prater
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Salary: $200,000 - $300,000 per year

A bit about us:

Our client is a contract research organization, a type of organization that plays a vital role in the development of new treatments and medications for patients. They specialize in a variety of therapeutic areas including Transplants, Oncology, Rare Disease & Cell & Gene Therapy.

Why join us?

In addition to PTO, company-paid holidays, medical, dental and vision insurance our client also boasts the following!

• Our client has a structured mentoring program to provide the support you need to move forward
• Our client provides tuition reimbursement and partners with universities and colleges to create programs in our field, and have a dedicated training department
• Our client has never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
• Our client has received multiple awards recognizing it as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
• Our client has consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride itself on our average 95% annual retention rate
• Annual Target bonus
• 3+ weeks PTO
• Company credit card for travel expenses

Job Details

Job Purpose / Summary

Laboratory Oversight & Administrative

Provide effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory.
Ensure that qualified personnel are employed; by defining the qualifications and responsibilities of all laboratory technical staff and documenting training and/or competency.
Specify in writing the technical and administrative responsibilities and duties of all laboratory personnel.
Ensure all technical staff has current and up to date licensing and credentials.
Delegate the responsibilities of the Laboratory Supervisor, Specialty Laboratory Directors/Supervisors, Quality Control Manager and Testing Personnel to employees who are qualified to perform such duties.
Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory test.
Monitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported.
Provide advice to sponsors and clients regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient/subject interpretation.
Participate in the selection of partner laboratories.
Ensure that a supervisor provides onsite supervision of high complexity test performance.
Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA, etc.
Oversee and maintain relevant laboratory testing and reporting, laboratory and clinical trial files and other laboratory documentation to ensure inspection readiness at times.
Lead the development and continuous improvement of laboratory SOPs, and GLPs and provide oversight of laboratory quality & adherence to established processes and plans.
Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments, and reagent/control/instrument qualifications, quality audits, deviation approval requests, and nonconforming event reports.
Maintain an effective working relationship with applicable accrediting and regulatory agencies.
Subject Matter Expert for client interactions and business development activities
Report all concerns of test quality and/or safety to Vice President, Global Laboratory Services.

Laboratory Quality Management System (QMS)

Working with the Manager Quality Assurance to support and enforce all aspects of the laboratory's QMS to ensure conformance to requirements described in the Quality Management System and Clinical Laboratory Practice Standards including management of outcomes and non-conformities, participation in internal quality control system monitoring, and performance in proficiency testing.
Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory Services provided and to identify failures in quality as they occur.
Assure that laboratory participates in monitoring and evaluating the quality and appropriateness of services rendered, within the context of the Quality Management System, regardless of where the testing is performed.
Ensure that the laboratory is enrolled in the appropriate proficiency testing program for the testing performed.
Effectively implement a plan of correction to deficiencies identified.
Perform and document monthly quality audits of all testing equipment to ensure optimal accuracy and performance.
Laboratory Information Management System (LIMS)
Working with the IT Manager in selection, implementation and management of LIMS

Personnel Management

Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills.
The laboratory director is responsible for competency assessment of direct-report supervisors; Documentation of assessments must be performed regularly and whenever new systems are introduced; Remedial steps must be documented when staff does not perform as expected.
Provide continuing educational to laboratory technical staff that is relevant to laboratory medicine.
Ensure that an approved procedure manual is available to all personnel.

What You'll Bring
A Medical Degree (MD) or Doctoral degree (PhD) in clinical laboratory science, chemical, physical, or biological science that meets the requirements to be a High Complexity Laboratory Director under CLIA/CAP.
7-10 years' experience as a Laboratory Director with administrative responsibilities
Previous experience across multiple clinical disciplines.

Certification:
Must meet the license requirements of the position set by the State(s)
Must possess training and/or experience, obtained within the previous six years, in generally accepted and currently used methods and techniques in one or more categories listed below and must meet one of the following requirements:
Be a physician who is currently certified by the American Board of Pathology in: Clinical Pathology; or an area of special competence relevant to the certificate of qualification sought; or be a physician or hold an earned doctoral degree from an accredited institution with a relevant chemical, physical or biological science major.
Is currently or willing to get certified by any of the following: The American Board of Medical Microbiology, The American Board of Clinical Chemistry, The American Board of Clinical Chemistry, The American Board of Forensic Toxicology, The American Board of Medical Laboratory Immunology, or The American Board of Internal Medicine in Hematology.
Subsequent to receiving a Doctor of Medicine, Doctor of Osteopathy or earned doctoral degree, has had documented four years of training and/or experience in an acceptable laboratory. The training and/or experience must have been in methods and techniques currently in use in the certificate category or categories sought and in general laboratory management, or an equivalent combination of training and/or experience!

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