University of Rochester Project Manager, Clinical Trials - 228807 in Rochester, New York
Project Manager, Clinical Trials Job ID 228807Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 052 Path&Lab Clinical TrialsResponsibilities
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:
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.
Ability to adjust work schedule if needed to meet project timelines and milestones.
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 . required.
Programming and statistical programming knowledge preferred.
Desired candidates will have project management and clinical trials experience, effective written and verbal communication, computer and organizational skills, ability to work a flexible work schedule, and knowledge of laboratory and phlebotomy operations.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled