Clinical Project Manager

at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States

Job Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Title: Clinical Project Manager

Department/Group: Clinical PM

Location: Rockford or Remote

Reports to: Senior Clinical Project Manager, Senior Manager, Clinical Project Management or General Manager, US Clinical Services

FLSA Status: Exempt

Prepared By: Brian Keesee
Approved By: Brian Keesee

Summary of Objective:
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. 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 US and PCI UK 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.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

1. Accountable for overall project management for assigned projects using appropriate project planning tools. Communicates milestones, critical path activities and assign internal and external responsibility to ensure the project achieves all deliverables per the customer requirements and agreed upon timeline.
2. Primary customer contact for clinical packaging activities and relationship management with the Customer Project Teams.
3. Coach, mentor, and supervise the Associate Clinical Project Managers.
4. Responsible for leading Clinical Project Team and Technical Kick-Off Meetings for assigned projects.
5. Provide support to business development and estimation regarding new quotations and resupplies.
6. Assessment of clinical protocols, study specifications, contracts, and other documentation to ensure we mitigate risk and provide our clients with the best service and experience.
7. Provide the client with the highest level of professionalism, quality of work, communication/responsiveness, and status of deliverables.
8. Effectively facilitate a lessons learned with the client at the conclusion of every study to ensure we capture best practices, receive constructive feedback, and develop solutions and action plans to make the next project a bigger success.
9. In-depth understanding of clinical trials and supplies.
10. Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects.
11. Forecasting and managing project expenses in adherence with the project budget. Generate customer invoices against an itemized sales order to ensure proper billing and revenue.
12. Review and approve internal customer-based specifications for packaging components and processes.
13. Provide suggestions for packaging solutions in the areas of design and specification management.
14. Host and manage customer visits at PCI.
15. Travel to client sites for new project discussions or quarterly business reviews.
16. Reviews Quotes to ensure scope is appropriate. Initiates change orders where necessary. Monitors project budget and scope creep.
17. Ability to travel between 10 and 30 % of the year by car and/or airplane.
18. This position may require overtime and/or weekend work.
19. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
20. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
Stationary Position: From 1/2 to 3/4... For full info follow application link.

LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.