University of Rochester CMSU Clinical Materials Project Manager, Assoc - 221463 in Rochester, New York
CMSU Clinical Materials Project Manager, Assoc Job ID 221463Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Schedule
8 AM-5 PM; OCC WKENDSResponsibilities
The Clinical Materials Services Unit (CMSU) is a Core research unit of the Center for Health + Technology. The responsibility of this client-facing role as the Clinical Materials Project Manager, Associate is to direct and coordinate all aspects of clinical supplies (drugs/devices/components) for multi-center international clinical research trials.
Under general guidance and with latitude for the exercise of independent judgment and initiative:
Directs and oversees the planning, implementation, coordination and supply chain of clinical supplies to support multi-center clinical trials sponsored by industry, government or private organizations/foundations. Plans internal meetings and provides professional direction within clinical materials services unit team.
Serves as liaison to study sponsors, clinical coordinating centers, data coordinating centers, clinical trial sites, pharmacy departments, contract research organizations, study principal investigators, study medical monitors, biostatistics department and administration/fiscal unit.
Drafts and develops the CMSU’s Clinical Materials Specifications Sheet (CMSS), processing orders, shipping instructions, packing lists/Acknowledgement of Receipts (AOR’s) and study drug handling instructions.
Develops and presents slide presentations for the study drug sessions at investigator meetings.
Actively participates, along with the CMSU management team, in the development of project budgets and proposals as a part of the Request for Proposal (RFP)/business development process.
Coordinates with sites for the return of clinical materials to the CMSU.
Develops, facilitates, and delivers training programs to support new processes and projects.
Anticipates departmental needs based on established clinical plans for the ordering of all packaging components critical to the assembly of finished study supplies.
Schedules and facilitates project team meetings both internally and with sponsors on a regular and ad hoc basis.
Develops and manages the monthly production calendar to ensure all on-going projects remain on track for initial and resupplies.
Other projects and job duties as necessary.
Bachelor’s degree, with major course works in appropriate health, social science, or biological science field; or equivalent combination of education and experience.
3-5 years of relevant clinical trials/supplies experience.
Knowledge of Good Manufacturing Practices and Good Clinical Practice, planning, implementation and coordination of clinical trials.
Clinical trials project management experience preferred. Travel required (up to 5%).
Strong communication skills, including written communication.
Strong presentation, interpersonal and organizational skills, and attention to detail.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled