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Clinical Associate Project Man
3 months ago
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.
Supports 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. 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:
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 and Clinical Project Team meetings in absence of Project Manager or as designated. Creates notes for weekly customer teleconference calls and internal Clinical Project Team meetings. Creates project specific documentation including packaging/labeling protocols, variable data forms, sample shipment request forms, monthly finished goods inventories, logistics instructions, returns accountability worksheet, monthly distribution reports. 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 Clinical Project Coordinator with production needs for project. Creates project specific bills of material. 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. Identifies lot specific drug product and components for production job staging. Works with customers and sites to resolve discrepancies on end of study returns. Creates Destruction Authorization Forms and forwards to customer for destruction approval of returns, remaining finished goods, and customer owned inventories. Assists in monthly packaging and distribution invoices processing. Records data in project specific metrics. Resolves shipment delivery issues by working closely with distribution group, carriers, customer, and clinical sites. 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 trouble-shooting. Accountable for assigned project tasks using appropriate project planning tools. Host and manage customer visits at PCI as necessary. Support cross-functional leadership on improvement opportunities and strategic initiatives. Participate in meetings and reporting with Project Management, Operations, and Quality management. 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. Attendance to work is an essential function of this position. Performs job duties as assigned by Manager/Supervisor.QUALIFICATIONS:
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.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.#LI-RS1
Join us and be part of building the bridge between life changing therapies and patients.
