University of Rochester Sr Project Manager, Clinical Trials - 230744 in Rochester, New York
Sr Project Manager, Clinical Trials Job ID 230744Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 054 Path&Lab Clinical TrialsSchedule
8 AM-4:30 PMResponsibilities
POSITION SUMMARY :
Under general direction from the Manager, Project Management, and with considerable latitude for independent judgment, manages multi-center clinical trial programs and clinical research projects for the clinical trials central laboratory. Assume full responsibility for study requirements 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. Provides support to the Business Development and Finance Group in the development of proposals and budgets. Negotiates and documents project specifications and implements work processes to meet customer requirements. Monitors project progress, communicates timelines and requirements to clinical trials department staff.
SUPERVISION AND DIRECTION RECEIVED:
Reports directly to the Manager, Project Management for Clinical Trials.
SUPERVISION AND DIRECTION EXCERCISED:
Assumes a departmental supervisory role in the absence of the Manager, Project Management.
JOB RESPONSIBILITIES :
Train, coach and mentor team members
Participates in developing clinical trials standard operating procedures.
Trains staff on project specific procedures.
Provides direction on daily and weekly priorities for team activities.
Develops and monitors metrics for staff activities.
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.
Develop relationships with new clients and preserve relationships with current clients
Relay any client issues with appropriate internal teams such as Quality Assurance, Business Development, Kit Production,
Other related duties as assigned.
Bachelor’s degree with major coursework in social or technical field, a minimum of four (4) years’ experience in the analysis and dissemination of information, supervisory experience or an equivalent combination of education and experience required.
Master’s degree in a related field preferred.
Desired candidates will have clinical trials project management experience; effective communication, organizational and computer skills; the ability to work a flexible schedule; and laboratory and phlebotomy experience.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled