Manager, BioPharma Biospecimen Management
Found in: Resume Library US A2 - 2 weeks ago
About the Role:
The Manager of Biospecimen Management is responsible for the supervision of Biospecimen Management Associates, Lead(s) and Supervisor(s). The Manager may supervise the daily operation of the Laboratory. The Manager monitors quality control and quality assurance, writes and reviews standard operating procedures, addresses issues, and takes remedial action when needed. The Manager ensures laboratory staff is correctly trained on all processes. The Manager demonstrates good judgment, sound analysis and decision-making, the ability to remain professional and composed under pressure, and the ability to communicate effectively across levels and functions. The Manager will ensure that the Biospecimen Management Lab team adheres to CLIA and CAP standards. The Manager complies with all applicable local, state, and federal laboratory requirements and operates under the direction of the Laboratory Director and Director of Biospecimen Management.
Essential Duties and Responsibilities:
Oversees BioPharma and Investigational Sponsored Trial sample processing for BSM
Collaborates with Sustain and Support, Clinical Operations, and Clinical Trials Operations to meet retrospective batch processing schedule, resolve project issues, and meet turnaround times
Coordinates remnant sample and cold storage chamber management with Pharma partners, Biorepository team, and Facilities
Collaborates with Technology Development to accommodate requests for non-standard workflows
Identify systemic issues and drive efficiency improvements for pharma workflows
Collaborate with Facilities department to manage San Diego shipments
Works with Clinical Study Coordinators to process all trials-related documents and assist in preparation for monitoring visits and audits
Engages with Quality to ensure timely initiation and resolution of DARs, NCRs, CAPAs, and complaints
Supports pharma partner audits and inspections
Provides supervision of the Biospecimen Management Supervisor(s) and Lead(s), may supervise other Biospecimen Management personnel and also daily procedures
Writes and reviews standard operating procedures, performs other administrative duties, including but not limited to: writing and reviewing employee performance evaluations, protocols, clinical trial sample tracking and equipment maintenance forms
Works closely with the Clinical Operations Supervisors and Client Services Department in developing efficiencies/processes between the functional areas to ensure that SOPs and best practices for each department are met
Reviews and documents routine preventive maintenance
Oversees training and competency of new and existing laboratory personnel
Represents the Biospecimen Management Department in cross-functional meetings
Manages and leads department projects and goals
Supports the Biospecimen Management team and is responsible for the daily operations of the laboratory including but not limited to scheduling, independently troubleshooting and resolving problems; and
Reports all quality and/or safety concerns to the Laboratory Director or Safety Officer.
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