The Role:

 

Overall responsibility for quality of laboratory processing for assigned duties To ensure study data is collected to a high quality in accordance with ICH-GCP, protocol and lab manual  To ensure subject safety at all times 

Main Tasks and Responsibilities:

Provides encouragement, support, positive reinforcement to laboratory technicians Oversees sample labelling, processing and shipping duties as required Ensures lab set up and cleaning duties are performed on a daily, weekly and monthly basis Processes biological samples as per lab manual when required Attends all pre-study meetings, including SIVs and protocol trainings for assigned studies Reviews/Approves lab manual prior to the start of a study Ensures sample shipments are organized and sent to clients as per the lab manual and study timeline Ensures sample shipment checklists and sample manifests are generated and reviewed for all sample shipments Performs sample processing checks on all studies to ensure compliance with lab manual and SOPs  Ensures the QC of laboratory source data and performs QC as necessary Works in a safe and responsible manner at all times Reviews protocol specimen processing requirements and ensures that an adequate inventory of necessary supplies are available or ordered and delivered prior to study start and throughout study conduct Reviews/approves specimen labels prior to tube preparation Ensures collection tubes and freezer vials are properly labelled and set up prior to scheduled sample collection Processes samples and assists with laboratory duties as needed Assists with SOP reviews and edits Works with Data Entry team to resolve discrepancies/queries noted during lab tracking or monitoring visits Assists with training of new laboratory staff and ensures lab staff are fully trained and signed off in the relevant SOP/competency and protocols before working unsupervised or on a study May serve as a back up to the Clinical Laboratory Manager when required 

The Candidate:

Laboratory / Sample processing experience essential Education or equivalent experience in a science, health or customer related field  Supervisory experience preferred