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Quotient Sciences · 4 hours ago

Clinical Laboratory Lead

Miami, FL

Full-time

Onsite

Mid, Senior Level

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. The Clinical Laboratory Lead will oversee the quality and compliance of laboratory processing for clinical studies, ensuring accurate data collection and maintaining subject safety while supporting a collaborative team.

Clinical TrialsCommercialConsultingHealth CareManufacturingMedicalPharmaceutical

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