The incumbent will lead the laboratory components of a phase III randomized controlled trial. She/he will work in coordination with the lab and project team; will ensure timely completion of project deliverables; and guarantees that study tests are performed correctly in the due time and that results are timely transferred to the endTB project team. In addition the TB laboratory study supervisor ensures that all study documentation is updated and available to the staff.
· Plan, supervise and delegate the day to day laboratory work for the endTB project activities.
· Ensure that the updated versions of the Analytical Plan, SOPs and other study documents are available in the laboratory and that are clearly understood by the staff.
· Provide regular training to the staff on revised study procedures.
· Ensure that the analytical plan, study flow chart, guidelines and SOPs are strictly followed.
· Ensure staff follow good laboratory practices, all safety instruction and Biosafety and Biosecurity policies of the organization.
· Ensure results of project are generated in a timely manner, kept updated, appropriately archived and shared with the endTB project team.
· Validate all results entries before releasing to the medical team.
· Review Daily QC and ensure lab meets QA defined by the endTB trial before releasing result.
· In collaboration with the data manager, addresses problems related to sample labelling and acts as a link between the laboratory staff, the study PI and the analytical project manager in ITM for any study deviation occurring in the lab.
· Informs the study site coordinator for any study deviation and ensures that the PI is also informed for major deviations.
· Supervise the filling of the register for nonconformities and ensure that all errors are corrected and properly reported in the activity report.
· Monitor project deliverables and timeliness, notify the Team Leader /Manager when issues arise, and take corrective actions, as needed.
· Participate to the regular meetings with the analytical project manager and file the minutes meetings.
· Organize and supervise the preparation of the biological material to be shipped to ITM.
· Identify technical and administrative problems and plan for corrective measures with Manager/Section Head.
· Manage laboratory procurement, inventory, storage and supplies usage.
· Operate and maintain equipment or ensure is appropriately done (daily maintenance), recognize equipment malfunction, troubleshoots as necessary, ensure preventive maintenance is done according to schedule.
· Participate in ordering; and monitor required levels of inventory, prevent stock-outs
· Participate in planning and budgeting for project deliverables.
· Intervenes with approved remedial action when defined parameters are exceeded.
· Reports status of activities to the Site endTB team, ITM central team and MSF Pakistan team as required.
· Provide documents required for the Investigator study file.
· Ensure that EQA results and Masterfile for equipment maintenance are updated.
· Prepares endTB trial activity reports and laboratory statistics for the analytical project manager and the site coordinator.
· Discusses the reports and overall trial activity with the analytical project manager and study site coordinator.
· Support the site internal monitor in the filling of the monthly monitoring tool.