As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address):

150 Metro Park, Rochester, New York, United States of America, 14623

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400982 Neuro-Ctr Health & Tech/CMSU

Work Shift:

UR - Day (United States of America)

Range:

UR URG 111

Compensation Range:

$63,815.00 - $95,723.00

Responsibilities:

Leads or coordinates cross-functional project/program teams from design to delivery of fully-developed products that are ready for customer use. Monitors performance and recommends schedule changes, cost adjustments or resource additions. Investigates facts and develops solutions to problems during the design and planning phases. Provides timely and accurate information and status updates to functional leaders. May be responsible for feasibility studies, field trials management, identifying product gaps, defining product requirements and engaging with customers to understand market needs and trends. Leads or coordinates cross-functional project/program teams from design to delivery of fully-developed products that are ready for customer use. Leads or coordinates cross-functional project/program teams from design to delivery of fully-developed products that are ready for customer use. Monitors performance and recommends schedule changes, cost adjustments or resource additions. Investigates facts and develops solutions to problems during the design and planning phases. Provides timely and accurate information and status updates to functional leaders. May be responsible for feasibility studies, field trials management, identifying product gaps, defining product requirements and engaging with customers to understand market needs and trends. Leads or coordinates cross-functional project/program teams from design to delivery of fully-developed products that are ready for customer use.

ESSENTIAL FUNCTIONS

• 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 the clinical materials service unit team.  Develop and deliver training programs to support new processes and projects.
• 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.   
• 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.
• Develops and presents slide presentations for the study drug sessions at investigator meetings.   
• Provides input to the monthly production calendar to ensure all ongoing projects remain on track for initial and resupplies. Schedules and facilitates project team meetings both internally and with sponsors on a regular and ad hoc basis. 
• Anticipates departmental needs based on established clinical plans for the ordering of all packaging components critical to the assembly of finished study supplies. Coordinates with sites for the return of clinical materials to the CMSU.   
• Other job duties and projects as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor’s Degree with major course works in appropriate health, social science, or biological science field required.
• Minimum 5-10  years of experience, or equivalent combination of education and experience required.
• Clinical trials project management experience preferred.  

KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of Good Manufacturing Practices and Good Clinical Practices, planning, implementation, and coordination of clinical trials.
• Travel required (up to 5%).
• Strong communication skills, including written communication.
• Strong presentation, interpersonal and organizational skills, and attention to detail.

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.