Senior Clinical Materials Project Manager

• 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
• Directs and oversees the planning, implementation, coordination, and supply chain of clinical supplies to support multi-center clinical trials
• 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

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

Clinical trials project management experience