• Forecast clinical supply demand and manage clinical supply inventory throughout the clinical trial globally• Utilize simulation tools and supply chain expertise to determine packaging campaign and distribution strategies• Work with IXRS vendors in creation of system specification for supply algorithms and manages drug supply portion of IXRS development for clinical trials• Manage clinical supply depot set-up and monitor depot inventory throughout study• Manage clinical drug for a wide range of study types including packaging design and contingency planning• Manages IMP across multiple clinical trials• Provides input for protocol development/amendment, as needed

• Assist in managing assigned teams represented in multiple projects from planning to analysis phase; represent multiple functional areas in specific project and could work on multiple projects simultaneously.• Coordinate project organization, implementation, and management activities.• Prepare Project Plan, timelines, schedules, resources, and budgets.• Assist with monitoring ongoing resource needs to the project.• Provide appropriate project tracking using computer-assisted programs and ensures timely entry of project information.• Participate in developing Project-Specific Operating Procedures (PSOPs), as necessary, with responsible functional areas.• Assist with assessing scope of work against client contractual agreements and suggests change of scope orders, when appropriate.• Prepare weekly and/or monthly project status reports for assigned projects.• Participate in conducting presentations at Investigator meetings. • Assists in providing day-to-day oversight of CRA tasks on assigned projects.

• Mange the distribution of drug and ancillary supplies to domestic and international clinical trial sites and drug depots.• Work with Sponsors to ensure timelines are met and effectively communicate any delays in a timely manner.• Coordinate resupply, return of product and accountability with Sponsor, CRO and Monitors.• Read and understand IP requirements of protocols, including understanding and following any required blinding.• Create protocol specific documents to be followed by internal departments and documents provided to sites with each shipment.• Support the Sponsor and sites on day-to-day queries.• Review quotes, complete change orders and create project invoices

• Experience with Phase I-III Protocols in Oncology, Infectious Disease, Metabolic Disorders• Work with a team to complete daily tasks of multiple clinical trials from site selection through closeout; support FDA inspections, if needed.• Coordinate activities with internal and external contacts.• Manage external vendors including IxRS, EDC, Contract CRAs and other CROs.• Create protocol specific tools: i.e. Monitoring Plan, ISF Documents, TMF Structure, Pharmacy Plans, Welcome Kits• Create enrollment projections and timelines; Complete Site Feasibility.• Develop and maintain trackers for project startup, protocol specific training, monitoring visit duration, patient schedules and others as needed.• Maintain the Trial Master File and perform internal or Sponsor driven audits of contents.• Act as the primary point of contact for CRAs, Sponsors, Vendors, internal team and international team.• Assist with the training of Interns, Project Coordinators and Clinical Trial Managers.

• Assist in drafting the initial contract and budget presented to clinical trial sites; Working with the customer to establish agreed to parameters.• Review and facilitate the negotiation of the contract and budget. • Work closely with Regulatory Submissions on startup activities. • Maintain timelines and present to study teams in weekly meetings.• Process payments to clinical trial sites on a monthly or quarterly schedule.

• Create and implement training materials on processes and system functions. Receive and inspect incoming shipments of pharmaceutical drugs.• Verify packaging and label content against approved proofs.• Work with Quality and Sales on the release or drug and processing of orders.• Schedule outgoing pickups daily with LTL freight companies and UPS.

• Organize youth sport camps and leagues. • Create marketing material and maintain contact database. • Attend local events as representative of sponsorship and to promote company. • Order promotional material. • Manage front office, including enrollment and scheduling. • Give facility tours to new athletes, parents and agents.