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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.
Job Responsibility:
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 CPT meetings in absence of Project Manager
Creates notes for weekly customer teleconference calls and internal CTP meetings
Creates project specific documentation including packaging specification, variable data form, sample shipment request forms, monthly finished goods inventories, logistic management document, returns accountability worksheet, monthly distribution billing spreadsheets
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
Creates project specific routings and bills of material
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
Hard allocates lot specific bulk and material to the work order
Works with customers and sites to resolve discrepancies on end of study returns
Creates Inventory Disposition Report and forwards to customer for destruction approval of returns, remaining finished goods and customer owned inventories
Processes monthly distribution invoices and records data in project specific metrics
Resolves shipment delivery issues by working closely with DSA 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
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
Attendance to work is an essential function of this position
Performs job duties as assigned by Manager / Supervisor
Requirements:
GCSE Grade C and above in English, Science and Mathematics (or equivalent) is essential
An understanding of Quality Standards including GMP, GCP and GDP
Experience in providing administrative support
Clear and concise communications
Attention to detail
Proficient in the use of J D Edwards and MS Office Packages
Excellent written and verbal communication
structures communication in a logical way
Nice to have:
A Level /NVQ/HNC or equivalent in Applied/Life Sciences or Mathematics is desirable
Experience in a supportive role, preferably in the clinical supply field and a contract environment
Motivated, self starter, able to work without supervision on own initiative on tasks set but is also a team player
Demonstrates a determination to succeed and is able to ‘push’ to make things happen
Is able to multi-task and handle tasks at the same time whilst adjusting to changing priorities and requests
What we offer:
Employer Pension: Secure your future with our employer pension scheme (above statutory pension)
Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions
Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays
Family Friendly Benefits: Enjoy a range of benefits designed to support your family life
Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!
Staff Engagement: We value your dedication with recognition schemes and long-service awards
Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary
Cycle to Work Scheme
Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options
Donation and More! PCI Cares is a new all-in-one platform allowing employees to give back to the community by donating to vetted charities and non-profit organisations and PCI will match your donation! In addition, each employee will be granted 8 hours of paid Volunteer Time per year