University of Rochester Technical & Scientific Affairs Manager - Clinical Trials Division - 223918 in Rochester, New York
Technical & Scientific Affairs Manager - Clinical Trials Division
School of Medicine & Dentistry
Full Time 40 hours Grade 055 Pathology & Laboratory Medicine Clinical
Under the direction of the Medical Director, the Technical and Scientific Affairs Manager (Tech Mgr) for URMC Clinical Trials Central Laboratory (Clinical Trials) directs the operational management function for all facets of the Clinical Trials' pre-analytical areas, including the Specimen Logistics, Kit Building, and Medical Technologists sections.
The Tech Mgr serves as the primary contact for customers regarding scientific and technical information, and collaborates with internal scientific directors, various technical services, and laboratory operations in preparation of proposals to support customers. Provides scientific and technical advice to the internal project management and business development teams. The Tech Mgr will also work with the Medical Director to oversee the Clinical Trials sections' relationships with Pathology Department Clinical Laboratories, URMC core laboratories, and third party specialty/reference labs.
Reports to the Medical Director of the Clinical Trials Lab. Directly reporting to the Tech Mgr are the Supervisors for the Specimen Logistics, Kit Building and Medical Technologist sections.
Essential Job Functions:
Operational Management/Technical Performance:
Serves as primary technical and scientific liaison between Laboratory Operations and Business Development during the proposal development process.
Oversees scientific support of inquiries from other departments and client requests for specific laboratory information.
Collaborates with laboratory leadership throughout the Department of Pathology and Laboratory Medicine to communicate opportunities and facilitate implementation of new testing modalities.
Directs and oversees development and validation of moderate/complex laboratory testing.
Assists in evaluating the validity of specimen results per Standard Operating Procedures or guidelines.
Manages, assists in the development, and reviews standard operating procedures.
Assists in the development and oversees technical instruction and training protocols.
Oversees and monitors compliance with all safety and infection control protocols.
Effectively manages project deadlines.
Works with Medical Director to continuously analyze staffing, financing, operations, systems, and procedures to ensure effective operations and to proactively adapt to internal and external changes.
Supports personnel matters in collaboration with leaders of Kit Building, Specimen Logistics, and Technologists, working closely with the Medical Director and HR Business Partner.
Establishes and meets standards of behavior creating an atmosphere of teamwork and respect. Promotes and sets accountability for a just culture and an engaged workforce.
Accountable for the operational and professional performance of all section employees.
Oversees the performance evaluation process.
Appropriately follows Human Resource policies, recommends actions as to recruitment, hiring, transfer, promotion, disciplinary action, and termination. Interviews a diverse candidate pool.
Oversees staff training and documentation.
Administers organizational Wage and Salary program, insuring equity and appropriateness of salary according to performance standards.
Works with the Medical Director to grow and refine the operational structure required to successfully operate the clinical trials business model.
Initiates, leads and communicates on a scientific level with scientific directors, preanalytical technical services, laboratories, specialty technologists, business development operations, and customers.
Models leadership skills of professionalism, positive attitude, team building, good judgement and respect. Encourages open expression of ideas and suggestions.
Builds relationships throughout the entire Department of Pathology and Laboratory Medicine.
Accepts accountability for responsible sections' overall performance.
Participates in operational meetings to help formulate and administer policies and procedures.
Responsible for disseminating operational information.
Develops and maintains current, accurate and appropriate job descriptions.
With the QA representative, oversees effective quality assurance and improvement programs.
Fosters an environment of teamwork and in doing it right the first time.
Experienced with federal, state, and local laws and standards of accrediting agencies (e.g., FDA, CLIA, CAP, OSHA) for all Clinical Trials Labs operational, business and financial activities, including operations in laboratories performing work under contract from or in collaboration with Clinical Trials Labs.
Understands the financial impact of operational decisions within assigned sections.Manages expenses in accordance with approved budget. Identifies and implements opportunities for reducing expenses and improving the efficiency of processes.
Performs other activities as assigned by the Medical Director, including assuming responsibilities of other personnel as needed.
BS and 5 years of relevant experience including at least 2 years at a managerial level; or equivalent combination of education and experience. Licensed Medical Technologist is preferred
How To Apply