Associate Clinical Project Manager

Contenuto del lavoro

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.

General Purpose Of Role

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.

Main 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 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 labeling 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.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position.
• Performs job duties as assigned by Manager/Supervisor.
  

Outcomes Of Role

• The on-time, on-budget delivery of client projects to relevant standards as a result of support provided to PM.
• Provision of reporting of Project Management metrics and KPI statistics as required.
• The active participation in improvements to departmental and cross company procedures and systems.
  

Specific Qualifications

• GCSE Grade C and above in English, Science and Mathematics (or equivalent) is essential
• A Level/NVQ/HNC or equivalent in Applied/Life Sciences or Mathematics is desirable
  

Specific Knowledge / Skills Competence

• Experience in a supportive role, preferably in the clinical supply field and a contract environment.
• 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.
  

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.