SDO_Clinical Project Manager
PCI Pharma Services
Summary
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 Global Project Manager between PCI US and PCI UK for global clinical studies where required. Responsible for all activities associated with a Clinical Distribution project.
Job description
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. Fill role of Lead Global Project Manager between PCI US and PCI UK for global clinical studies where required. Responsible for all activities associated with a Clinical Distribution project.
Essential Duties and Responsibilities
- Primary customer contact for storage and distribution activities, including business, relationship and customer expectation management matters.
- Prepare the Logistics Instructions 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 and ensure performance expectations are met or exceeded on a consistent basis.
- Coordinates storage and distribution activities from order receipt to shipment acknowledgement as per Logistics Instructions.
- Sets up returns accountability reports and manages returns, including drug destruction, as per the Logistics Instructions.
- Setup and provide inventory reports to meet customer requirements, identifies discrepancies, and manages resolution of inventory issues.
- 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 and mentor 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.
Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
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.
Requirements
- 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
- Ability 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
Benefits
- Paid Time Off
- Health Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Account
- 401(k) Plan
- Annual Performance Bonus
Company overview
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.