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Packaging Coordinators, Inc. Clinical Project Manager in Rockford, Illinois

Position Title: Clinical Project Manager

Location: Rockford, IL -- Assembly Drive

Department: Clinical

Shift: 1st

Reporting To: Sr. Clinical Project Manager or Sr. Manager, Clinical Project Management or General Manager, US Clinical Services

Responsible For (Staff): yes

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 and pharmaceutical regulatory requirements. Manage and play an integral part in strategic customer relationships and individual project success to provide PCI a competitive advantage in long-term customer management. Fill role of Lead Global Project Manager between PCI Global facilities 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. Accountable for overall project management including use of designated project planning tools, communication of milestones and critical path activities, and assignment of internal and external responsibilities to ensure all deliverables are achieved per the customer requirements and agreed upon timeline.

  2. Serve as primary customer contact for clinical activities and relationship management with the Customer Project Teams. Provide client with the highest level of professionalism, quality of work, communication, responsiveness, and status of deliverables.

  3. Coach, mentor, and guide Clinical Associate Project Manager.

  4. Lead Clinical Project Team (CPT) and Technical Kick-Off Meetings for assigned projects.

  5. Collaborate with business development for creation of quotes for new projects and resupplies, and change orders.

  6. Use critical thinking skills, logic and ingenuity to resolve issues and unique challenges while remaining within cGMP guidelines and PCI work practices and guidelines.

  7. Forecast and manage project expenses in adherence with the project budget. Generate customer invoices against an itemized sales order to ensure proper billing and revenue.

  8. Review and approve internal customer-based specifications for packaging components and processes.

  9. Provide suggestions for packaging solutions in the areas of design and specification management.

  10. Host and manage customer visits at PCI.

  11. Travel to client sites as appropriate.

  12. Develop an in-depth understanding of clinical trials and supplies.

  13. Ability to travel between 10 and 30 % of the year by car and/or airplane.

  14. This position may require overtime and/or weekend work.

  15. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

  16. Create and maintain the customer specific production schedule for both long-term forecast and short-term production demands; follow up on the workflow through each step to maintain schedule integrity and communication. Communicate any OTD risks.

  17. Understand and interpret application of purchasing authorization from the supply agreement; Place purchase order requisitions with procurement and work with them to expedite, delay or cancel if necessary; ensure on-time delivery and communicate any issues with on-time delivery. Support fulfillment and application of MRP tools in ERP system though forecast and order management.

  18. Track OTD and jacket issuance metrics for the appropriate business units

  19. Manage and monitor purchase order statuses within the organization to ensure On-Time Delivery metrics are met.

  20. Review and approve documentation including specifications and batch records, as required.

  21. Attendance to work is an essential function of this position

  22. Performs other duties as assigned by Manager/Supervisor.

Special Demands:

  • Stationary Position: From 1/2 to 3/4 of the day.

  • Move, Traverse: Up to 1/4 of the day.

  • Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.

  • Install, place, adjust, apply, measure, use, or signal: None.

  • Ascend/Descend or Work Atop: None.

  • Position self (to) or Move (about or to): None.

  • Communicate or exchange information: 3/4 of the day and up.

  • Detect, distinguish, or determine: Up to 1/4 of the day.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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