Project Manager - Clinical

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.

The primary responsibilities of this position are:

• 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 for the customer requirements and agreed upon timelines.

• Primary customer contact for clinical packaging activities and relationship management with the customer project teams for assigned projects/customers.

• Creates and reviews project specific documentation including master batch records, finished product specifications, sample shipment request forms, printing and issuance form requests, bill of materials spreadsheets.

• Ensures labels design and text is in accordance with the study set up. Monitors and updates scheduling liaison with production needs for project.
• Coach, mentor, and train other new team members in an equivalent role and the Associate Project Managers / Coordinators
• 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.

• Responsible for leading Clinical Project Team and Technical Kick-Off Meetings for assigned projects and works closely with internal and external customers.

• Provide support to business development for the estimation of new proposals and change orders as needed.

• 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 lesson 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.

• Hard allocates lot specific bulk and materials to production labelling activities as needed.

• 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.
• In-depth understanding of clinical trials and supplies.

• In liaison with the Distribution project team, ensure clinical supply is maintained.
• Leads and creates minutes/agendas for customer calls for assigned projects.
• Facilitates the billing of all activities involved labelling activities.

• Supports project close out activities.

• Coordinates Customer visits and facilitates activities as per customer needs.
• Forecasting and managing the project budget.

• Reviews Quotes to ensure scope is appropriate, initiates change orders where necessary and monitor project budget and scope creep.

• Works closely with internal groups and vendors to ensure project milestones are achieved, including labelling and component design and delivery and on-time shipments of order requests.
• Processes and records data in project specific metrics.

• Maintains and updates project plans and timelines.

• 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.

• Executes continuous improvement projects as assigned by Director/Manager/Supervisor.

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

• Attendance to work is an essential function of this position however, opportunities to work from home are also offered.

• Performs job duties as assigned by Director/Manager/Supervisor.

The mandatory qualifications & experience:

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.

• Basic Mathematical Skills

• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

• Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.

• Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.

• Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
• 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 & experience:

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

The behavioural competencies required for this position:

• Positive, embraces and responsive to change

• Clear communication and collegiate

• Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision, Values and Pristine Customer Service

• Analytical thinker and solution finder/problem solver

• Collaborative, team player

• Objective and robust decision maker

• Excellent interpersonal, written and verbal communication

• Self-motivated and achievement orientated

• Trusting and trustworthy

• Conscientious and diligent

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, Equity and Inclusion 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.