Laboratory Team Lead

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