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University of Rochester Senior Manager - Clinical Trials Project Management - 228961 in Rochester, New York

Senior Manager - Clinical Trials Project Management Job ID 228961

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

Full Time 40 hours Grade 055 Pathology & Laboratory Clinical Trials



Under general direction from the Administrative Director, Clinical Trials and with considerable latitude for independent judgment, the Senior Manager of Clinical Trials Project Management manages the operational and administrative duties for all the project management personnel of the Clinical Trials section.


Supervises project team members (Project Managers, Project Associates, Administrative Assistants).


  • Administration/Leadership (40%)

  • Manages, leads, and oversees a team of Project Managers, Associate Project Managers, and Administrative Assistants.

  • Models leadership skills of professionalism, positive attitude, team building, good judgement and respect.

  • Accountable for overall performance of team’s project portfolio.

  • Designs and implements operational structure and workflow required to successfully implement the clinical trials business model.

  • Demonstrates initiative in improving operational and functional performance with effective decision-making, planning and implementation skills. Encourage open expression of ideas and suggestions.

  • Develops goals and objectives for clinical trials section that are in alignment with departmental goals in collaboration with faculty and administration

  • Serves as a point of escalation to internal and external stakeholders

  • Represents Clinical Trials Project Management in client meetings and audits

  • Assigns projects to Project Managers, and monitors capacity ensuring proper work load balances

  • Translates departmental policies into effective section procedures.

  • Oversees compliance with and effectiveness of departmental and section procedures; recommends revision as needed.

  • Coordinates and consults with laboratory administration other departmental managers to insure integration and synchronization of various laboratory operations. Supports strategic initiatives.

  • Participates in laboratory and hospital management meetings and committees and conducts regular staff meetings; follows up on issues and responds to inquiries in a timely fashion.

  • Collaborates closely with leadership to insure smooth integration of testing/reporting, compliance and quality assurance related to clinical trial client deliverables.

  • Personnel Management (35%)

  • Accountable for operational and professional performance of all employees. May include development and mentoring of staff in order to achieve departmental goals. Oversees project management staff for Internal and Multi-Center Studies, as well as any clerical support positions.

  • Oversees performance evaluation process, insures fair and accurate evaluation following standards of performance. Provides counseling and constructive feedback for employee development

  • Ensures that Departmental and Organizational Human Resource policies and procedures are followed and makes recommendations for hiring, transfer, promotion, disciplinary action and termination.

  • Participates in the recruitment process.

  • Accountable for staffing including adequacy of staffing levels, training and training documentation and equity of scheduling.

  • Administers organizations wage and salary program, ensures equity when establishing compensation rates.

  • Establishes and models excellence in communication, teamwork and respect.

  • Develops and maintains accurate and appropriate position descriptions in accordance with organizational standards.

  • Operational Management/ Performance (15%)

  • Keeps abreast of current advances in the clinical trials project management field and acts to evaluate and implement changes as appropriate.

  • Monitors individual and team performance, sets objectives, and establishes training and development plans for Project Management Team

  • Provides daily operational direction) to staff through work assignments.

  • Develops and oversees instructional and training protocols.

  • Participates in the education of residents, medical students, fellows, and laboratory staff/students.

  • Manages the continual compliance with all regulatory requirement and agencies and ensures ongoing compliance and adequate documentation.

  • Oversees compliance of operations, including but not limited to safety, infection control and housekeeping policies and procedures.

  • Designs and implements processes, oversees, and continually monitors the efficient operation of the section.

  • Demonstrates thorough understand of the daily operations and gives timely follow up to issues and questions.

  • Quality (5%)

  • Develops and administers an effective Quality Assurance program measuring the critical aspects of service and compliance with Quality Assurance requirement of relevant regulatory agencies, (ex: FDA, NYS, CAP,). Monitors and evaluates results of program, adequacy of indicators, and compliance of staff and faculty with the program. Implements improvement actions.

  • Proactively seeks information to improve work processes, and researches and implements solutions to problems in a timely manner.

  • Understands and demonstrates the mission, vision and values of the University of Rochester.

  • Fosters an environment of teamwork and doing it right the first time.

  • Financial Performance (5%)

  • Manages operating expenses in accordance with an approved budget.

  • Demonstrates fiscal responsibility and understands the financial impact of operational decisions.

  • Manages purchasing activities, and identifies and implements opportunities for reducing expenses and improving the efficiency of section processes.

  • Conducts timely reviews of business reports, identifies trends, initiation corrections and/or recommends modifications as needed.

  • Develops business plans to justify changes/requests including but not limited to requests for additional staff, capital equipment and/or supplies based on new procedures or volumes, technology changes or replacement of systems.

  • Prepares annual operational and capital budget.

  • Other related duties as assigned.


  • Bachelor's degree and 5 years relevant experience including at least 2 years at a managerial level; or equivalent combination of education and experience. Master's degree, equivalent course work, or specialized experience in an appropriate field related to the assignment is desirable.

  • Desired candidates will have clinical trials project management experience; effective communication and leadership skills; central laboratory experience.

    How To Apply

All applicants must apply online.

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