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University of Rochester Clinical Trials Project Manager - 232795 in Rochester, New York

Clinical Trials Project Manager Job ID 232795

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

Full Time 40 hours Grade 052 Path&Lab Clinical Trials

Responsibilities

POSITION SUMMARY :

Under general direction from the Manager, Project Management and Senior Project Manager with considerable latitude for independent judgment, manages multi-center clinical trials and clinical research projects for the clinical trials central laboratory. Assume full responsibility for study requirements, conduct and ensure client goals are met on time. Represents the needs and expectations of external pharmaceutical industry clients by implementing services to support multi-center clinical trials. Negotiates project specifications and creates work processes to meet customer requirements. Manages project progress, communicates timelines and requirements to clinical trials department staff. Routinely interfaces and works collaboratively with all clinical trial and laboratory team members.

SUPERVISION AND DIRECTION RECEIVED:

Reports directly to the Manager, Project Management and receives direction from Senior Project Manager.

SUPERVISION AND DIRECTION EXCERCISED:

None

SPECIFIC JOB RESPONSIBILITIES :

  • Serves as the main point of contact and project lead for external and internal clients.

  • Maintains a high level of customer service and satisfaction

  • Develops and implements project plans and timelines

  • Monitors project timeline and manages the financial components of assigned project

  • Ensures project deliverables are within scope and budget

  • Proactively monitors project budget

  • Responsible for all aspects of the project including start up, maintenance and close out phases

  • Identifies potential risks, mitigations, and escalates appropriately

  • Constructs overall project development based on review of protocol and contract. Including interpretation of project deliverables not identified during the sales phase of the study Participates in development of project related documents

  • Manages and maintains all study documentation in accordance with standard operating procedures

  • Collaborates with laboratory regarding specimen requirements.

  • Trains staff on project specific procedures.

  • Leads internal and external project meetings with key stakeholders.

  • Collaborates with the Quality Assurance department to create quality improvement plans.

  • Develops presentations and presents UR Central Lab’s services at Investigator Meetings, Sites, and Kick off Meetings

  • Participates in study monitoring visits and audits conducted by external auditors.

  • Develops Services Specifications Document, Investigator Manuals and Internal Statement of Work

  • Designs sample collection instructions and processing procedures

  • Develops project specific procedures and monitoring plans.

  • Develops forms and labels required to identify samples submitted for testing

  • Determines supply requirements for clinical trials projects and communicate material needs to Kit Production

  • Provides support with discrepancy resolutions and report printing

  • Participates in validation activities

  • Other duties as assigned.

REQUIREMENTS:

  • Experience in clinical trials/pharmaceutical field, specifically in Project Management

  • Good Understanding of Clinical Trials is preferred

  • Ability to interact effectively and professionally with co-workers, customers, and vendors.

  • Excellent computer and organizational skills.

  • Ability to adjust work schedule if needed to meet project timelines and milestones.

  • Adhere to all departmental and organizational policies and procedures

  • Demonstrates all aspects of Strong Commitment and ICARE Values

  • Previous laboratory experience preferred in understanding human blood and tissue collection, including phlebotomy requirements, tube types and sample stability.

    QUALIFICATIONS :

    Bachelor's degree with major course work in social or technical field and some graduate level course work in that field, and 1-2 years of experience in the analysis and dissemination of information; or an equivalent combination of education and experience. Strong Project Management and Clinical Trials experience preferred. Knowledge of programming and statistical programming packages would be helpful.

    How To Apply

All applicants must apply online.

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