The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.
- Job Summary:
The Supervisor will report to the Operations Manager/Associate Director.
The primary role of the Supervisor is to ensure that all procedures in the Sample Management Group are performed in compliance with applicable regulatory requirements, and specifically those regulations, GLP, GCP specified in the study plans, protocols or work agreements governing the work in which they are involved.
- Duties and Responsibilities:
- To ensure all samples in are entered, located and tracked by established deadlines and in compliance with SOPs and regulatory agency guidelines.
- To supervise all the activities of a team of operational staff responsible for the processing and management of samples.
- Responsible for ensuring that procedures carried out by their team are carried out in a timely and cost effective manner which requires accurate and also flexible scheduling.
- Supervision of a team of Sample Coordinators; organisation of studies to meet protocol requirements; identification and allocation of resource requirements; monitoring performance; appraisal and development of staff; knowledge of company policies.
- Individual has a responsibility to conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GLP, GCP) specified in the study plans, protocols, or work agreements governing the work in which they are involved
- Ensures daily schedules and priorities are met reporting any deviations to line manager
- Fosters a ‘continuous improvement’ environment within the sample management group, reviewing working practices and recommending best practice to line manager.
- Assure chain of custody for all samples arriving on site.
- Assess data for SOP and protocol compliance. Reviews paperwork involved in entry and posting of samples.
- Entry of sample demographic information.
- Data clean up-Identification and prompt reporting of discrepancies during sample receipt.
- Internal and external label production and QC checking.
- Performs any combination of sample accession tasks, including opening, entering, and posting of samples.
- Reviews sample inventory against samples received to ensure accuracy and communicate discrepancies.
- Communicates receipt of samples to clients and Study Directors.
- Acts as a lead coordinator handling internal and external customer inquiries and requests.
- Distributes sample information and paperwork to appropriate cost centres.
- Responsible for upkeep and accuracy of sample tracking systems for the appropriate area.
- Anticipates day –to –day priorities for the group and implements resolutions as required.
- Ensures receipt and despatch of samples meets SOP standards.
- Takes immediate corrective action and advises line manager of action taken
- Reports discrepancies to manager.
- Maintains well-documented records according to regulatory requirements.
- Acts as focal point for internal and external clients in the absence of line manager.
- Train and direct less experienced staff and provide advice to members of the group as required
- Consults with manager regarding overall planning, scheduling and scientific problems, but is personally responsible for issues arising and decision making.
- Schedules daily tasks to coincide with study deadlines.
Performs other related duties as assigned
- Principal Contacts
- Internal – Sample Coordinators, Shift Leaders, Supervisors, Study Directors, Operations Manager, QA, Dispensary, Scientific Services Metrology, AH Ops, CPS, CMC, CCRU Leeds.
- External – Client tours of the department, answering client queries.
- Travel Requirements: No
- Language Skills Required:
- Speaking: No
- Writing/Reading: No
BSc degree in Chemistry/Biology or similar plus at least 5 years relevant experience. Experience may be substituted for education
- Knowledge of GLP, GCP, H+S and regulatory requirements is required.
- Working knowledge of LIMS systems or equivalent and scheduling systems.
- Experience of Bioanalytical and CPS processes and procedures is essential.
- Good communication skills and an ability to work within appropriate company procedures
- Ability to utilise word processing, databases, spreadsheets, and specialised software on personal computers.
- The post holder should be recognised as being an expert in their area of responsibility and be able to demonstrate a consistent track record of high achievement.
Leadership Competencies: Manager
V. Working Conditions:
Immunisation: Hepatitis A, Hepatitis B, TB, Rabies required
VI. Special Factors:
No special physical requirements, however some lifting and manual dexterity skills may be required.
- Overtime and weekend work as required.
- Mandatory immunisations and screening as required.
- May work with potentially hazardous substances.