Clinical Supply Project Manager - Packaging and Labelling

1 Days Old

Job Description

This is a fulltime, permanent position working a 35 hour week flexibly Monday - Friday between 07:00 - 19:00

This scope of work involves managing activities related to the production of clinical trial labels and finished clinical supplies utilizing internal (client) and external contracted resources to meet clinical study design requirements. The scope of work covers the following activities.

Job Responsibilities:

  • Supports delivery of clinical supplies through effective management of assigned clinical project packaging projects. Liaise with Trial Supply Managers (DSM) on aspects of clinical supplies packaging and labelling design, production scheduling options that enable on-time delivery of desired supplies, SAP demand entry, SAP material creation and other related purchasing activities.
  • Manages multiple projects. Responsible for coordinating deliverables of assigned projects (e.g. product, code and label text) with production schedules. Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects. Identifies and reports issues to appropriate levels of management in a timely manner.
  • Generates internal packaging and labelling and label print production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Responsible for the creation and/or release of BOMs and process orders for assigned projects within SAP, including relevant checks on order accuracy, etc.
  • Sources labels from approved label vendors. Supports the CSO outsourcing strategy through monitoring compliance with applicable Master Service, Technical and Quality Agreements with identified vendors and completion of vendor quality metrics..
  • Manages any assigned labelling requests and outsourced packaging and labelling at approved vendors
  • Drives collaboration with CSO, Analytical and Quality colleagues to ensure on-time testing and release of assigned projects
  • Ensures regulatory and GMP compliance of activities in assigned areas of responsibility, through monitoring and management of vendor performance and reporting any deviations immediately to the appropriate line management and Quality unit.
  • Supports GMP compliance through conducting assigned investigations for deviations and contributing to maintenance of the CSO Risk Register.
  • Authors new and/or reviews existing procedural documents. Ensures processes remain in compliance with current GMP, superior BMS procedural documents and are aligned with relevant business practices.
  • Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.
  • Participates in assigned training including CGMP and safety training. May provide staff training as identified.
  • Ensures project management and outsourcing operations are sustainable at all times through development of self and others such that technical support is maintained across the breadth of services provided.
  • Responsible for checking BOMs, change and process orders for other Project Management Coordinators.
  • Manages auxiliary labelling requests and outsourced packaging and labelling at an approved vendor.

    • Qualifications

  • BSc degree in Life Sciences, IT or related field or equivalent qualification. Significant relevant experience may be considered in lieu of educational qualifications
  • Some experience in clinical supplies project management.
  • Relevant experience working in a GMP regulated industry
  • Strong problem solving skills and ability to work effectively with other teams and individuals to resolve problems, schedule and prioritise work. This will include working across geographies on cross-functional teams
  • Ability to work accurately to deadlines in a fast-paced, rapidly changing environment.
  • Excellent communication skills, both written and oral.
  • Strong interpersonal skills
  • Ability to develop and share knowledge and teach others in the areas of clinical trial label generation and production.
  • Working knowledge and understanding of MRP systems (i.e. SAP).

    • Additional Information

    Benefits

    At Eurofins we are growing, innovating and always learning. We celebrate the achievements of our employees through annual long service awards, recognise our colleagues special life events, and we are committed to charitable causes through global fundraising activities.

    As a Eurofins employee you will benefit from:

  • Reward and Recognition.
  • Health Cash Plan
  • Life Assurance (4 times annual salary).
  • Company Pension Plan
  • Employee Assistance Programme – 24/7 confidential support.
  • Free car parking
  • Worldwide career opportunities
  • Everyone who joins our team also gets access to Perkbox, allowing you to save money all year round. Whether its supermarket savings or days out, the daily coffee or a summer holiday – there’s something to suit everyone’s lifestyle.

    • What Happens Next

    Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. 
     
    Your data 
    As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.

    We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

    Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!

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    Location:
    Liverpool
    Job Type:
    FullTime

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