Clinical Laboratory Manager
Position Summary and Overview:
This role is responsible for the overall management of all laboratory operations and personnel providing services that are equivalent to a Leica’s USA customer laboratory, i.e. CLIA-certified High Complexity. In addition, this role will be responsible for ensuring all studies are conducted according to Good Clinical Practices (GCP) to ensure suitability of study data to be used on behalf of verification or validation of new products or claims. This role is intended to meet the essential expectations for personnel standards set forth under CLIA for a Laboratory Director, Technical Supervisor and General Supervisor.
- Manage and maintain a laboratory that mimics a High Complexity CLIA laboratory suitable to serve as a clinical trial site for Leica Biosystems under GCP.
- Coordinate and supervise the implementation of IVD clinical studies
- Responsible to ensure clinical research studies are conducted in compliance with GCP/ICH and local applicable regulations
- Work closely with the Study Sponsor to ensure the following tasks are completed: execute, and close-out of the study including collection of data, as described in the clinical protocol and in accordance with agreed timelines
- Work with the technical team to ensure the day to day activities of the study, including communication, protocol management and problem solving are completed
- Prepares documentation for routine on-site inspections and internal audits, responds to inspection and audit deficiencies
- Responds to any deviation to SOPs or issues related to Lab operations.
- Oversee and ensure resolution of data discrepancies at all stages of the study
- Management, coaching and mentoring of Clinical Testing team.
- Responsible for training and performance management of the Clinical Testing team.
- Provide both operational and scientific guidance on processes as required
- Monitoring performance to ensure all acceptable levels for performance are maintained
- Work with the QA /Regulatory, and Clinical Affairs teams to ensure that all work complies with SOPs
Additional Health and Safety Responsibilities:
- Provide so far as is reasonably practicable a healthy and safe workplace for employees, contractors and visitors
- Support EHS framework and assist in annual planning, implementation, evaluation and review
- Work with EHS Manager to implement policies, procedures and support improvements
- Support best practice safety performance levels and ensure business complies with all relevant EHS regulations
- Be actively involved in Workplace Inspections and Near Miss and Incident reporting
- Discuss and review statistical data (near misses, incident reports, etc) at monthly management meetings
- Ensure safety performance is included in annual staff reviews
- Relevant and demonstrable experience in a clinical laboratory in a relevant discipline (e.g histology, anatomic pathology).
- Previous experience of managing a clinical laboratory with commensurate experience in personnel standards, quality control, quality assurance, and proficiency testing.
- A track record of achievement and an ability to ensure accountability to ensure study needs are met on a sustained and timely manner
- Previous experience of with regulatory inspections (e.g. FDA BIMO) is highly preferred
- Proficient in Microsoft Word, Excel, PowerPoint (essential), Access and Project with previous experience in electronic data capture systems (desirable)
- Proven ability to effectively manage people, projects and processes in a high-paced, results focused environment
- Proven ability to work effectively at all levels of the organization
- Excellent interpersonal communication skills with proven ability to promote leadership and followership with excellent influencing skills.
- Self-starter and independent thinker with aptitude to work autonomously
- Ability to manage detail, ensure accuracy and produce results
- Ability solve problems under pressure and timely escalation if required
Education List of Education, Certifications, Training:
- Educated to minimum of degree level with clear evidence of CPD in diagnostics or clinical development industries
Travel % of Travel, include approximate overnight stays per week:
- Travel expectations within this role are moderate (<20%)
- This role is based within the Technical Services Department within Leica Biosystems Newcastle Ltd.
- This role reports into the Director, Technical Services