Group Leader Biosample Operations

Conteúdo do emprego

Position Summary

The Group Leader Biosample Operations is responsible for coordinating all activities required for the collection, shipment, tracking, reception, and storage of biosamples and study material at CellCarta. Reporting to the Associate Director Operations, the Group Leader Biosample Operations serves as the point of contact for study teams (including sponsors/central laboratories/clinical sites) for biosample operational questions and issues. The Biosample Operations Specialist assists the Scientific teams for the procurement of biological samples from different suppliers and possesses sufficient knowledge of ethics to ensure the procurement and use of human biological samples in accordance with current regulations.

Key Responsibilities

• Perform the day-to-day staff management for assigned team;
• Resolve scheduling conflicts along with other group/team leaders;
• Works with other team leaders to ensure staff is properly allocated;
• Ensures that the staff executes the work according to GLP and CellCarta SOP and CSP;
• Ensures that the staff performs the work in an efficient manner;
• Coaches staff on how to perform work appropriately and efficiently;
• Implements appropriate and effective corrective actions in the laboratory to minimize GLP deficiencies;
• Identifies staff training requirement and areas for career development;
• Follows-up with assigned staff on performance;
• Organizes and helps drive decisions on sample collection, logistics and shipping schedule before study initiation and during the study;
• Serves as the main point of contact for biospecimen procurement of future and current studies at CellCarta and assures that this is done under ethical regulations;
• Responsible for clinical site evaluation, and laboratory manual writing;
• Trains the clinical sites on the laboratory manual (e.g., blood processing and sample shipment);
• Maintains professional knowledge of current ICH, GCP, GLP, GCLP, biobanking, sample management policies, best practices, and ethical guidelines, and applies knowledge appropriately;
• Files, tracks, and reviews all related documentation in a timely manner.
• Assists in coordinating clinical sites, couriers, and clients to organize, monitor and ensure the delivery of study samples or study reagents in a timely manner;
• Checks that clinical site and/or central laboratories send samples according to agreed shipping needs and schedule, and assists in taking corrective actions where not the case;
• Contacts clinical sites to confirm sample collection dates and verifies pick-up is scheduled as needed;
• Contacts couriers to schedule sample pick-ups with needed packaging material and to follow-up on the shipments tracking;
• Assists the customs broker when needed for situations related to shipments;
• Notifies the laboratory and scientific team of the incoming samples, their delivery status, and their arrival;
• Confirms proper shipment conditions and delivery or communicates any discrepancies or shipment non-conformities to related individuals (including clinical sites and/or clients/collaborators);
• Compiles and evaluates temperature data reports and sends them to clients;
• Reviews reception forms when needed;
• Assists in ensuring that sample collection information is adequate for effective sample tracking and reconciliation;
• Assists on preparing the outgoing shipments of samples and study reagents to clinical sites and/or clients/collaborators;
• Maintains documentation relevant to the tasks at hand as per appropriate SOP and applicable GLP regulations and GCLP guidelines.

Education

• B.Sc. or M.Sc. in life sciences, preferably in immunology, biology, or biochemistry.
• 3+ years of experience in people management in addition to 3+ years in logistics in the science field

Knowledge and Skills

• Experience in leading and coaching a team;
• Experience in working in clinical studies at a clinical site or proven clinical/biological laboratory experience with evidence of involvement in the processing of biological samples;
• Experience in laboratory manual writing;
• Knowledge and understanding of GDP, and GLP, GCLP, and ICH regulations; knowledge of procedures and protocols for containment of biohazardous material; ability to understand safety procedures and guidelines;
• Knowledge of blood sample processing and cell cryopreservation techniques, and cell culture techniques;
• Knowledge of informed consent process and ethics guidelines;
• Proven effective and fluent communication skills, in both English and French (level B1-B2);
• Good organizational and influencing skills;
• Critical reasoning skills including the identification and resolution of complex problems;
• Experience in working in a GLP/GCLP environment;
• Very good knowledge of Microsoft Excel and Microsoft Word, and experience working with a LIMS;
• Available to adapt his/her schedule to accommodate business needs.