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University of Rochester Clinical Trials Technical Affairs Manager - 227871 in Rochester, New York

Clinical Trials Technical Affairs Manager Job ID 227871

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 055 Pathology & Laboratory Medicine Clinical

Responsibilities

POSITION SUMMARY :

Under the direction of the Medical Director and the Administrative Director, the Technical Affairs Manager (Tech Affairs Mgr) for URMC Clinical Trials Central Laboratory (Clinical Trials) directs the Technical Affairs functions for Clinical Trials and the Medical Technologist section.

The Tech Affairs Mgr serves as the primary contact for customers regarding scientific and technical information, and c ollaborates with internal scientific directors, various technical services, and laboratory operations to support business needs . Works closely with internal project management and business development teams to provide technical input for statements of work and business proposals. Works with the Administrative Director to collaborate with Pathology Department Clinical Laboratories, URMC core laboratories, and third party specialty/reference labs. Supports validation of internal Molecular and other assays.

Reporting Structure

Reports to the Administrative Director of the Clinical Trials Lab. Directly reporting to the Tech Affairs Mgr are the Medical Technologists.

Essential Job Functions

Operational Management/Technical Performance (50%)

  • Serves as primary technical and scientific liaison between Laboratory Operations and Business Development during the proposal development process.

  • Reviews and oversees the technical component of all internal study-related documentation.

  • Oversees scientific support of inquiries from other departments and client requests for specific laboratory information.

  • Directs and oversees development and validation of moderate/complex Molecular and other assays.

  • 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.

  • Effectively manages project deadlines.

  • Works with the Administrative Director to continuously analyze staffing, operations, systems, and procedures to ensure effective operations and to proactively adapt to internal and external changes.

Personnel Management (20%)

  • Supports Technologists personnel matters, working closely with the Administrative 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, and completes performance evaluations.

  • 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.

Quality (15%)

  • With the QA representative, oversees effective quality assurance and improvement programs.

  • Oversees and monitors compliance with all safety and infection control protocols.

  • 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.

Administration/Leadership (10%)

  • 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.

Financial Performance (5%)

  • 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.

Other - Performs other activities as assigned by the Medical Director, including assuming responsibilities of other personnel as needed.

Requirements

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.

NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.

How To Apply

All applicants must apply online.

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