Project Manager

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.

Purpose:

The Project Manager is responsible for the oversight of project set up in accordance with projects’ specifications and in compliance with regulatory requirements. This includes internal project handover, managing quotes/contracts required to conduct the study and to ensure appropriate disbursements, logistics management documents, specifications and management as per the project’s requirements and labelling as required. The Project Manager will liaise with clients at the relevant time points to allow the project to progress according to the agreed timelines.

The primary responsibilities of this position are to:

• Accountable for overall project management for assigned projects/customers using appropriate project planning tools. Communicates milestones, critical path activities, and assigns internal and external responsibility to ensure the project achieves all deliverables per the customer requirements and agreed upon timelines.
• Primary customer contact for distribution activities, including business and relationship management with the customer project teams for assigned projects/customers.
• Coach, mentor, and train other new team members in an equivalent role and the Associate Project Managers / Coordinators
• Creates and reviews project specific documentation including logistics management document, pharmacy manuals, IxRS specifications, master packing slips, sample shipment request forms, permits and customs clearance documentation, inventory report spreadsheets.
• 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.
• 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 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.
• In-depth understanding of clinical trials and supplies.
• Leads and creates minutes/agendas for customer calls for assigned projects.
• Coordinates distribution activities from order receipt to shipment acknowledgement as per Logistics Management Document.
• In liaison with the Warehouse team, sets up Returns Accountability Workbook and manages returns, including drug destruction, as per the Logistics Management Document.

• Facilitates the billing of all activities involved with distribution, returns, destruction, and project close-out activities. Manages 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.
• Maintains and updates project plans and timelines.
• Processes and records data in project specific metrics.
• Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects.
• Participates in PCI internal audits and third-party audits and assist in responding to audit findings and product complaint investigations as may be required.
• This position may require overtime and/or weekend work.
• Attendance to work is an essential function of this position.
• Performs job duties as assigned by Manager/Supervisor.

The mandatory qualifications and experience for this position are:

• Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
• 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
• Documented cGMP/cGCP training

The desired qualifications and experience for this position are:

• 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.
• Experience with ERP systems (SAP, JDE etc.)

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

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.