CRSL Laboratory Manager

Laboratory Manager

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The Clinical Research Support Laboratory (CRSL) is the primary non-CLIA certified laboratory responsible for collecting, processing, stabilizing, documenting, shipping, and tracking all research biospecimens from patients participating in clinical trials supported by the Yale Cancer Center Clinical Trials Office in New Haven at Smilow Cancer Hospital as well as across the Smilow Cancer Hospital Cancer Center network. The Laboratory Manager supports the growth and development of the Yale Cancer Center (YCC) CRSL and is responsible for executing procedural, managerial, and policy decisions. The Laboratory Manager will oversee the physical lab facilities and is accountable for managing laboratory equipment and supply levels to ensure cost-effective, compliant, and efficient laboratory operations. This position is responsible for the development and maintenance of CRSL related policies and procedures and the CRSL quality control program. Oversees the daily operations of the CRSL laboratories, including implementing standardized workflows. Responsible for the development and maintenance of policies and procedures in support of the unit. Direct supervision of Laboratory Supervisors and the staff responsible for maintaining the inventory of kits and lab supplies. Responsible for recruiting, hiring, career development, performance evaluations, communication of deadlines and special circumstances, disciplinary actions, and day-to-day supervision of direct report employees within the CRSL. This position will provide direct supervision for a staff of exempt and non-exempt employees. Ensures appropriate staffing and resource levels for departmental functions. Represent CRSL at relevant meetings. In collaboration with others, develops and coordinate a program of continuing education and training for CRSL staff. Investigates complaints and collaborates with others as necessary to resolve issues arising within the unit. Escalates to management all important information necessary to ensure department success. Assists in strategic and long-range planning and budgeting processes. Provides study-specific training at the time of subject enrollment (required by the sponsor or special training / new lab function) and overviews CRSL staff to ensure adherence to study protocol. Interacts with external sources to coordinate work necessary to fulfill projects, keep abreast of new products and technologies, or arrange for subcontractors. Evaluates work requests to determine if they are appropriate to the unit or another area. Interacts with University personnel to define work assignments and requirements, communicate progress of work, and plan and coordinate projects. Manages and maintains an inventory tracking system that streamlines CRSL distribution and operations and ensures accurate product inventory. Maintains laboratory technology systems, equipment and supplies for unit. Maintains equipment inventory and works with appropriate departments and vendors for regular maintenance/service. Maintains knowledge of the regulatory environment governing the collection, storage, and shipment of human samples. Sustains up-to-date best practices and participates in local and international professional organizations, as appropriate. Performs other duties as assigned.

Required Skills and Abilities

1. Excellent interpersonal skills and ability to relay information to/obtain information from internal staff as well as external study staff, and demonstrated ability to supervise and manage lab staff. Ability to think strategically, analytically and influence constructive change with strong collaboration and relationship building skills.

2. Demonstrated ability to ensure appropriate infrastructure by interpreting complex clinical trial protocols and lab manuals to evaluate the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies, and regulation while ensuring participant safety.

3. Proven ability to work in a lab. Advanced technical expertise in complex specimen processing procedures and familiarity with BSL-2 laboratory standards. Ability to travel to different laboratory locations.

4. Excellent time management and organizational skills. Ability to meet daily deadlines while handling multiple projects. Ability to manage projects that are outside current areas of expertise, and willingness to learn new things to adapt to evolving environment.

5. Strong computer skills including intermediate proficiency with MS Office specifically Word, Excel, and PowerPoint; knowledge with or ability to learn additional software including OnCore and EPIC.

Preferred Education, Experience and Skills:

Master's degree in a health or research related discipline. Previous clinical trials experience and/or experience in an oncology setting. Previous experience with supply chain management. Previous laboratory operations experience strongly preferred. Proven experience supervising staff.

Principal Responsibilities

1. Reviews and determines staffing needs, job posting requirements, salary guidelines, and labor agreement interpretations for exempt and non-exempt staff in one or more functional department of the University. 2. Manages the administrative support needs for exempt and nonexempt staff and provides recommendations, improvements, solutions and assistance as needed. 3. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 4. Develops and prepares budgets, financial forecasts, and financial analyses and the actual vs. budgeted performance reports for the departments. 5. Manages the use of facilities in one or more departments including office space, work stations, equipment, and office supplies. 6. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 7. Manages and coordinates training sessions for assigned departments when new policies or practices are adopted. 8. Ensures compliance with University and federal regulations as they apply to the assigned departments. 9. Identifies, plans, and develops administrative policies for the assigned departments. 10. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 11. Assesses and makes recommendations regarding staff development and staffing levels. 12. Monitors, develops, plans, and executes systematic research on user requirements through such mechanisms as surveys, interviews, focus groups and competitive analysis. 13. Manages a staff of exempt and non-exempt employees. 14. May perform other duties as assigned.

Required Education and Experience Bachelor's Degree in related field and 5 years of experience or an equivalent combination of education and related experience.