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

Position Title: Clinical Associate Project Manager

Location: Rockford, IL -- Assembly Drive

Department: Clinical

Shift: 1st

Reporting To: Sr. Manager, Clinical Project Management or Sr. Project Manager

Responsible For (Staff): no

Supports 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. 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. Responsible for completing critical tasks required for clinical production while ensuring accuracy and completion on-time.

  2. Creates project specific documentation including packaging specification, variable data form, label request forms, sample shipment request forms, monthly finished goods inventories, logistic management document, returns accountability worksheet, monthly distribution billing spreadsheets, etc.

  3. Route documentation for internal and external approval. Answer questions from stakeholders and make corrections if needed.

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

  5. Provide continuous support to Project Manager and stay up to date on basic status of client projects owned by the team.

  6. Responsible for managing internal receipt and release of material. May include working with warehouse, procurement, labeling, client, quality and lab to ensure all materials are available when needed as well as resolution of Non-Conforming Material Reports.

  7. Submit production schedule requests to meet needs for project. Monitor schedule, identify and participate in resolving conflicts or delays.

  8. Participate in customer calls (weekly and ad hoc). Leads these calls in absence of Project Manager.

  9. Create and publish client-facing agendas and minutes for weekly customer teleconference calls.

  10. Ensure Shipment Requests are shipped on time and work urgently with client, Orders Team, and warehouse to resolve any issues that may arrive to eliminate patient impact.

  11. Responsible for tasks related to project set-up, pre-production tasks related to work orders, S&D Billing, printing of inventoried documents, etc.

  12. Work with customers to resolve discrepancies on end of study returns. Create accurate Inventory Disposition Report upon client request and obtain approval for destruction of material.

  13. Assist in hosting customer visits at PCI.

  14. Training and on-boarding of new employees, as requested.

  15. Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable.

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

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

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

  19. Performs job duties as assigned by Manager/Supervisor

Special Demands:

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

  • Move, Traverse: From 1/2 to 3/4 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: From 1/2 to 3/4 of the day.

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

On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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