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University of Rochester CMSU Clinical Materials Project Manager, Assoc - 221463 in Rochester, New York

CMSU Clinical Materials Project Manager, Assoc Job ID 221463

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Schedule

8 AM-5 PM; OCC WKENDS

Responsibilities

Position Summary:

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.

Responsibilities:

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.

    Qualifications:

  • 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.

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