Clinical Associate Project Manager II

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.

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.  Drives project success through effective planning and internal resource allocation.  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:

• 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 clinical packaging and/or distribution activities and relationship management with the customer project teams for assigned projects/customers.
• Provide support to business development and estimation regarding new quotations and resupplies.
• In-depth understanding of clinical trials and supplies.
• Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and trouble-shooting. Leads weekly customer calls in absence of Project Manager.
• Creates notes for weekly customer teleconference calls and project kick off meetings.
• Creates project specific documentation including Packaging and labelling Approval Forms (PLAF), print request forms, label proof request forms, and item and bill of material set up forms.
• Create metrices for business review meetings (BRM) upon request from business development.  
• Create shipment request form, logistic management document and monitor and provide shipping updates to client for both domestic and export shipments. Create change orders (CO) and monitor client budget using Master Quote.
• Enter the packaging revenue in ERP system and keep the status updated prior to weekly sales calls.
• Manages timing of internal process to ensure timely receipt and release of bulk, project packaging components and shipping supplies.
• Communicates with customers and vendors to resolve missing or erroneous certs and documentation related to receiving and QC release of bulk, packaging components and shipping supplies.
• Monitors and updates scheduling liaison with production needs for project. Submit Global Compliance Ticket to facilitate all the documents for Importer of Record.
• Work with Global Logistics team to set up a third-party depot as per the project requirements.
• Works closely with internal groups and vendors to ensure project milestones are achieved, including labeling and component design and delivery and on-time shipments of order requests.
• Works with customers and sites to resolve discrepancies on end of study returns.
• Creates Inventory Disposition Report/destruction reports and forwards to customers for destruction approval of returns, remaining finished goods and customer owned inventories.
• Review monthly clinical invoices prepared by a specialist billing team.
• Issue the credit memo for any invoicing discrepancies.
• Assist Finance in follow-up of outstanding invoices from client as needed. Assumes the role of the client advocate and acts as secondary client communication point for clinical packaging, storage, and distribution for assigned projects.
• Acts as back-up Project Manager contact for internal communications and troubleshooting.
• Host and manage customer visits at PCI.
• Training and on-boarding of new employees within same role, as requested. Maintains and updates project plans and timelines as requested.
• Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Performs job 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.
• Previous experience in lead role managing a clinical project.
• College Level 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.

Preferred:

• 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.

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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, 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.