SDO_Clinical Project Manager

About the role

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.

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.

• 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.
• Primary customer contact for clinical packaging activities and relationship management with the Customer Project Teams.
• Coach, mentor, and supervise the Clinical Project Managers and Associate Clinical Project Managers.
• Responsible for leading Clinical Project Team and Technical Kick-Off Meetings for assigned projects.
• Provide support to Business Development and estimation regarding new quotations and resupplies.
• 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.
• Provide the client with the highest level of professionalism, quality of work, communication/responsiveness, and status of deliverables.
• Effectively facilitate a lessons learned with the client at the conclusion of projects to ensure we capture best practices, receive constructive feedback, and develop solutions and action plans to make the next project a bigger success.
• In-depth understanding of clinical trials and supplies.
• Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects.
• Forecasting and managing project expenses in adherence with the project budget. Ensure customer invoicing against an itemized sales order is completed for proper billing and revenue.
• Review and approve internal customer-based specifications for packaging components and processes.
• Provide suggestions for packaging solutions in the areas of design and specification management.
• Host and manage customer visits at PCI.
• Travel to client sites for new project discussions or quarterly business reviews.
• Reviews Quotes to ensure scope is appropriate. Initiates change orders where necessary. Monitors project budget and scope creep.
• Lead and/or participate in independent or cross-functional improvement and strategic initiatives.
• Ability to travel between 10 and 30 % of the year by car and/or airplane.
• 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.

Qualifications

Required

• Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• Ability to Travel
• May have Supervisory Responsibilities.

Preferred

• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display excellent time management skills.
• Ability to work independently and/or as part of a team.

Pay and benefits

The hiring rate for this position is $76,000-$95,000 plus eligibility for an annual 10% performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future