University of Rochester Clinical Trials Project Manager - 212590 in Rochester, New York
Clinical Trials Project Manager
Medical Faculty Group
Full Time 40 hours Grade 052 Pathology & Lab Medicine
Under general direction from the Senior Manager, Products and Services for Clinical Trials and with considerable latitude for independent judgment, manages multi-center clinical trials and clinical research projects for the clinical trials central laboratory. Represents the needs and expectations of external pharmaceutical industry clients by implementing services to support multi-center clinical trials. Collaborates with internal University of Rochester researchers and faculty to design laboratory services for grant submissions and funded research projects. 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.
Develops project service specifications and timelines.
Prepares laboratory services specifications documents to capture customer requirements.
Negotiates and prepares project schedules; communicate timelines to staff.
Leads project team meetings and conference calls with customers.
Collaborates with laboratory Supervisors and staff regarding specimen requirements.
Develops appropriate sample procurement and transport procedures.
Trains staff on project specific procedures.
Prepares necessary materials and documentation for projects.
Designs sample collection instructions and processing procedures.
Develops forms and labels required to identify samples submitted for testing.
Develops laboratory manual content for investigators.
Develops project specific procedures and monitoring plans.
Determines supply requirements for clinical trials projects and communicates material needs to the Kit Production Coordinator.
Monitors project progress. Communicates project status information to internal and external sources.
Executes study data monitoring plan.
Identifies opportunities for quality improvement.
Collaborates with the Quality Assurance department to create quality improvement plans.
Communicates project indicators to internal management.
Communicates key indicators to customer as appropriate.
Validates study parameters.
Writes study validation plans and submits for quality approval.
Executes validation test cases.
Writes validation summary reports.
Participates in investigator meetings and project kick off meetings, including overnight travel.
Participates in study monitoring visits and audits conducted by external auditors.
Other duties and projects as assigned.
Bachelor’s degree in a related field, with 1-2 years of experience in the analysis and dissemination of information; or an equivalent combination of education and experience. Experience in Clinical or Anatomic Pathology, quality systems, and/or familiarity with the regulatory environment is preferred.
Ability to maintain a friendly and courteous professional manner at all times. 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. Ability to travel overnight, domestically and internationally, to attend investigator training and project meetings.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled