University of Rochester Senior Project Manager in Rochester, New York
Full Time 40 hours Grade 054 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 trial programs and clinical research projects for the clinical trials central laboratory. Provides support to customers from the pharmaceutical industry and researchers within the University of Rochester in planning and implementing clinical trials and research projects. Provides support to the Business Development department 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.
- Supervises the daily activities of project team members.
- Assigns project tasks to study team members.
- Develops 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.
- Develops project service specifications and timelines for complex and global projects and protocols.
- Develops operating processes and procedures for projects requiring collaboration with subcontracted vendors.
- Negotiates and prepares project schedules; communicates timelines to staff and subcontracted vendors.
- Collaborates with laboratory Supervisors and staff regarding specimen requirements.
- Determines appropriate standardized sample procurement and transport procedures.
- Participates in investigator meetings and project kick off meetings, including overnight travel.
- Participates in project team meetings and conference calls with customers.
- Prepares necessary materials and documentation for projects.
- Develops sample collection kits, assists in the selection of standard departmental kit materials.
- Determines needs for product validation for packaging and shipping materials.
- Participates in the selection of technology and applications used to support clinical trials and research studies.
- Develops content and design templates for investigator laboratory manuals.
- Monitors project progress. Communicates project status information to internal and external sources.
- Oversees monitoring plans for multiple studies and research programs.
- Participates in study monitoring visits and audits conducted by external auditors.
- Identifies opportunities for quality improvement and collaborate with the Quality Assurance department to create broadbased quality improvement plans.
- Communicates project indicators to department management.
- Communicates key indicators to customer as appropriate.
- Supports Business Development Activities.
- Provides input for proposals and presentations.
- Provides input for the development of project budgets.
- Participates in customer presentations.
- Identifies and communicates opportunities for expanded business with existing customers.
- Participates in sales presentations, bid defense meetings, industry conventions, and project kick off meetings, including overnight travel.
- Performs the essential functions of a Clinical Trials Project Management Associate or Project Manager as needed.
- Other duties and projects as assigned.
Bachelor's degree in a related discipline such as Computer Science, Business, Mathematics, Statistics, Science, or Engineering, and 2-3 years of related experience; or an equivalent combination of education and experience. Advanced degree preferred. Experience in laboratory research or managing clinical trials is a plus.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Senior Project Manager
Location: Medical Faculty Group
Job ID: 209872
Full/Part Time: Full-Time