Laboratory Team Lead - Permanent Full Time
Position Purpose:
The purpose of this role is to oversee the laboratory requirements for a portfolio of clinical trials assigned by the Laboratory Manager (LM), managing the laboratory setup from initiation to archiving, while supporting the LM as a team leader by mentoring, overseeing, and recruiting laboratory technicians and assistants, managing direct reports, and ensuring compliance with NZCR Policies and Procedures, study protocols, Good Clinical Practice Guidelines (ICH-GCP), Good Laboratory Practices (GLP), Standard Operating Procedures (SOPs), and applicable regulatory requirements.
Responsibilities:
Line Management
* Manages direct reports (Laboratory technicians and Laboratory assistants), including leave, timesheets etc.
* Ensures team works cohesively and collaboratively to meet all project goals.
* Works with the team members to delegate and prioritise direct reports’ tasks. Allocates tasks to team members based on their performance and skill sets.
* Works closely with LM to provide leadership, training, mentoring and professional development opportunities to team members.
* Works closely with other Laboratory Team Leads to share experience/learnings and resource, as required.
* Works with LM to ensure team resourced adequately.
* Reports to LM on any team workload challenges, process improvements suggestions etc.
* Works with HR and LM to recruit team members as required, including being part of interview panel for new team recruits.
* Orientates new team members, ensures training program in place, and monitors ongoing development.
* Acts as trainer to approve competencies on SOPs for direct reports.
* Provides feedback to team member regarding performance informally and formally at Annual Performance Review.
* Guides team on issues that require NTF, provides advice regarding CAPA, liaises with QA Manager as required.
* Supports LM with documentation reviews such as SOPs/WIs/templates/NTFs.
* Supports LM with audit preparation and participates in audits as appropriate.
Laboratory
* Support day-to-day operation and maintenance of laboratory, including document creation and QCing in accordance with study protocols and NZCR’s Standard Operating Procedures (SOP).
* Provide QCing support to other NZCR departments on documents such as workbooks, handover instructions etc.
* Oversee sample shipment according to study specific schedules and IATA standards.
* Contribute to team meetings such as the Study Initiation Visit (SIV) and Planning and Logistics (PaL) to ensure all study-related laboratory processes are in place.
* Performs other job-related duties as assigned.
* Oversee kit/supply levels and ensure stocks in place for the smooth running of studies; collaborate with the Accounts dept. to ensure pass through costs are identified and invoices are appropriately assigned to projects.
* Provide training and support for staff on the isolation of Peripheral Blood Mononuclear Cells (PBMC) and/or biopsy processing and ensure team members maintain accurate documentation.
* Provide support to resolve queries raised by other NZCR departments as well as external vendors.
* Liaise with Study coordinators, PIs and external vendors (e.g., CRA, local/central lab representatives) to ensures all study-related laboratory requirements are met.
Quality
* Maintain compliance with all New Zealand Clinical Research standards, protocols, and regulatory requirements, adhering to Good Clinical Practice (GCP).
* Regularly evaluates, documents, and refines clinical and operational processes to enhance accuracy, consistency and overall quality.
* Assists in training employees in quality standards, policies and procedures, ensuring all team members understand and implement best practices.
* Ensures accuracy, consistency, and currency in all research documentation and reporting, including accurate record-keeping, version control and timely updates.
Workplace Health and Safety
* Champions a culture of health and safety, ensuring preventative measures are in place to minimize risk to team members and participants.
* Actively identify and report health and safety hazards, accidents, incidents, injuries and property damage.
* Understands and complies with NZCR’s Health and Safety policies and procedures.
* Maintains adherence to all safety standards and processes.
* Commits to personal health and safety at work.
Minimum Position Qualifications
* Bachelors degree
* Preferred: Experience as a Senior Laboratory Technician
Knowledge, Skills and Experience
* Knowledge of the ethical principles, procedures, and regulatory requirements for clinical research.
* Ability to supervise and mentor new or junior team members.
* Ability to communicate constructively and effectively, both orally and in writing with colleagues and external parties at a variety of levels.
* Skill in organising resources and establishing priorities.
* Ability to foster a cooperative work environment and work effectively as a member of the laboratory team.
* Ability to analyse, develop, establish, and maintain efficient office workflow and administrative processes.
* Excellent organisation and planning skills
* Meticulous attention to detail
* Able to prioritise and enjoy working on several projects simultaneously with tight deadlines.
* Skilled in the use of a networked computer and Microsoft office applications
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