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Manages assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations. Fill role of Lead Project Manager for global clinical studies where required. Diligently manages significant matters pertaining to assigned projects to “Provide the industry’s leading customer experience” supporting PCI Clinical Service’s long term growth and success. Responsible for all activities associated with a Clinical Distribution project.
Job Responsibility:
Manages assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations
Fill role of Lead Project Manager for global clinical studies where required
Diligently manages significant matters pertaining to assigned projects
Responsible for all activities associated with a Clinical Distribution project
Primary customer contact for distribution activities, including business, relationship and customer expectation management matters
Prepare the Logistics Management Document as it pertains to the customer’s specific study
Assist in the development of detailed pack construction to ensure that the packaging is designed in a way that allows for efficient storage and distribution
Coordinates project activity by leading the Distribution Project Team and through working closely with the Clinical Project Management team as well as internal and external customers
Interacts with customers, vendors, and internal PCI colleagues to deliver service excellence
Coordinates distribution activities from order receipt to shipment acknowledgement as per Logistics Management Document
Sets up Returns processes and manages to include drug destruction, as per the Logistics Management Document
Manages project close out activities
Facilitates the billing of all activities involved with distribution, returns, destruction, and project close-out activities
Coordinates customer visits and facilitates activities as per customer needs
Reviews quotes to ensure scope is appropriate. Initiates change orders where necessary. Monitors project budget and scope creep
Coach, mentor, and supervise the Associate Clinical Project Managers
Provide support to business development and estimation regarding new quotations and resupplies
Provide the client with the highest level of professionalism, quality of work, communication/responsiveness, and status of deliverables
This position may require overtime and/or weekend work
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor
Requirements:
Preferably qualified in a scientific discipline (degree, HNC or equivalent)
Experience in a client facing role, preferably in the clinical supply field and a contract environment
An excellent understanding of Quality Standards including GMP, GCP and GDP. Familiar with concepts of risk management
Experience in managing projects, change and growth
Clear and concise presenter to internal/external customers
Proficient in the use of JD Edwards ERP system
Excellent written and verbal communication
structures communication in a logical way. Matches influencing style to the person and/or situation and secures positive outcomes through negotiation